Recall Register

Months

Recalls in August 2015

64 vehicle campaigns · 28 product recalls · 153 FDA events

In August 2015 NHTSA received 64 vehicle recall campaigns (down from 66 in July 2015) covering about 2,245,120 vehicles and other products, plus 9 equipment, tire or child-seat campaigns.

The CPSC announced 28 consumer product recalls (down from 33) covering about 3,294,522 units, and FDA posted 153 enforcement events (down from 215): 84 device, 45 food and 24 drug, 105 Class II, 32 Class I and 16 Class III.

64NHTSA vehicle campaigns66 in July 2015
2,245,120units in NHTSA campaigns
28CPSC product recalls33 in July 2015
153FDA enforcement events215 in July 2015

Monthly reports:Feb 2015Mar 2015Apr 2015May 2015Jun 2015Jul 2015Aug 2015Sep 2015Oct 2015Nov 2015Dec 2015Jan 2016Feb 2016

NHTSA vehicle and equipment recalls

CampaignManufacturerFirst vehicle listedComponentTypeUnitsReceived
15V519000General Motors LLCBuick Lacrosse 2008 +19Exterior LightingVehicle429,17014 Aug 2015
15V483000Volkswagen Group of America, Inc.Volkswagen GTI 2012 +28Air BagsVehicle415,8254 Aug 2015
15V507000Nissan North America, Inc.Nissan Versa 2013 +5Vehicle Speed ControlVehicle298,74712 Aug 2015
15C003000Britax Child Safety, Inc.Britax Advocate Clicktight +2Child SeatChild seat213,75311 Aug 2015
15V534000Chrysler (FCA US LLC)Ram 1500 2014 +1Air BagsVehicle188,04721 Aug 2015
15V509000Chrysler (FCA US LLC)Jeep Cherokee 2014VisibilityVehicle158,68412 Aug 2015
15V541000Chrysler (FCA US LLC)Ram 3500 2014 +2SteeringVehicle149,08026 Aug 2015
15T016000Michelin North America, Inc.BF Goodrich Commercial T/A A/S 2 +2TiresTire104,00010 Aug 2015
15V500000General Motors LLCChevrolet Cobalt 2010Air BagsVehicle59,47410 Aug 2015
15V486000Nissan North America, Inc.Nissan Altima 2014 +3Fuel System, GasolineVehicle46,8464 Aug 2015
15E068000Ricon CorporationRicon S5005 +5Equipment Adaptive/MobilityEquipment38,00021 Aug 2015
15V533000Ford Motor CompanyFord F-650 SD 2011 +7Seat BeltsVehicle25,94120 Aug 2015
15V542000Chrysler (FCA US LLC)Dodge Dart 2012 +2Power TrainVehicle23,56425 Aug 2015
15E069000Alpine Electronics Of America, Inc.Alpine Audio AmplifierEquipmentEquipment13,91427 Aug 2015
15V508000Chrysler (FCA US LLC)Jeep Renegade 2015Electrical SystemVehicle7,81012 Aug 2015
15V520000BMW of North America, LLCBMW 328XI 2014 +31Exterior LightingVehicle7,72717 Aug 2015
15V491000DRV SuitesDRV Elite Suites All 2014 +19Exterior LightingVehicle7,4655 Aug 2015
15V504000Mitsubishi Fuso Truck of America, Inc.Mitsubishi Fuso FEC52 2012 +10Service Brakes, HydraulicVehicle7,10411 Aug 2015
15E066000Fontaine Fifth Wheel CompanyFontaine Ultra LT Fifth WheelTrailer HitchesEquipment6,80014 Aug 2015
15V497000Volvo Cars of N.A., LLCVolvo XC90 2016Air BagsVehicle3,9116 Aug 2015
15V498000LGS Industries IncLook Cargo Trailer 2015 +5StructureVehicle3,6126 Aug 2015
15V510000Winnebago Industries, IncItasca Spirit 2014 +15Latches/Locks/LinkagesVehicle3,30712 Aug 2015
15V502000Subaru of America, Inc.Subaru Outback 2016 +3Power TrainVehicle2,89310 Aug 2015
15V524000Volvo Trucks North AmericaVolvo VNM 2012 +7Service BrakesVehicle2,85417 Aug 2015
15V515000Southeast Toyota Distributors, LLCToyota 4Runner 2010 +5Engine and Engine CoolingVehicle2,53013 Aug 2015
15E067000Reyco GranningReyco Granning Front SuspensionSuspensionEquipment2,01620 Aug 2015
15V490000Winnebago Industries, IncWinnebago ERA 2015 +4EquipmentVehicle1,7325 Aug 2015
15V518000Grand Design RV, LLCGrand Design Reflection 2015 +2EquipmentVehicle1,72114 Aug 2015
15V517000Chrysler (FCA US LLC)Ram 1500 2015 +1Electrical SystemVehicle1,65514 Aug 2015
15V501000Nissan North America, Inc.Nissan Armada 2015Seat BeltsVehicle1,55410 Aug 2015
15V546000Mitsubishi Motors North America, Inc.Mitsubishi Lancer Evolution 2014 +3Fuel System, GasolineVehicle1,49731 Aug 2015
15V503000Goshen CoachGoshen Pacer LS 2014 +25SeatsVehicle1,49410 Aug 2015
15V523000Volvo Trucks North AmericaVolvo VAH 2012 +4SteeringVehicle1,31917 Aug 2015
15V537000BMW of North America, LLCBMW G 650 GS 2013 +4Electrical SystemVehicle1,06024 Aug 2015
15E070000Holley Performance Products, IncNOS Nitrous Oxide SystemFuel System, OtherEquipment1,02027 Aug 2015
15V506000Strick Trailers, LLCStrick DRY Freight van Trailer 2013SuspensionVehicle1,00611 Aug 2015
15V514000Southeast Toyota Distributors, LLCToyota Prius C 2015TiresVehicle94913 Aug 2015
15V536000McNeilus Truck & Manufacturing, Inc.McNeilus ZR 2013 +5EquipmentVehicle80921 Aug 2015
15V495000Starcraft RVStarcraft RV TT Launch Ultra Lite 2016 +1EquipmentVehicle7056 Aug 2015
15V540000Spartan Motors USASpartan Gladiator 2014 +7StructureVehicle69625 Aug 2015
15V493000Forest River, Inc.Forest River XLR 2015 +1Electrical SystemVehicle6345 Aug 2015
15E065000Marmon-HerringtonMarmon-Herrington Drive AxlePower TrainEquipment52514 Aug 2015
15V499000Keystone RV CompanyKeystone Avalanche 2014 +4StructureVehicle40510 Aug 2015
15V512000Terex South Dakota, Inc.Terex Digger Derrick 2013 +3StructureVehicle38613 Aug 2015
15V538000McNeilus Truck & Manufacturing, Inc.McNeilus CNG Refuse Truck 2015 +3Fuel System, OtherVehicle36524 Aug 2015
15V530000Thor Motor CoachThor Motor Coach Vegas 2016 +1VisibilityVehicle29019 Aug 2015
15V545000Corp. Micro Bird Inc.Micro Bird G5 School Bus 2013 +2Electrical SystemVehicle28331 Aug 2015
15V505000Mercedes-Benz USA, LLC.Mercedes-Benz E400 2016 +5Engine and Engine CoolingVehicle20911 Aug 2015
15V516000Pierce ManufacturingPierce Enforcer 2015 +9Power TrainVehicle19113 Aug 2015
15V496000Forest River, Inc.Forest River Vengeance 2014 +1EquipmentVehicle1906 Aug 2015
15V529000E-One IncorporatedE-One Rescue 2015 +11EquipmentVehicle16418 Aug 2015
15V513000Halcore Group, Inc.AEV Traumahawk 2014 +1Back Over PreventionVehicle14013 Aug 2015
15E064000Emerson Process Mgmt Regulator Tech. IncFisher H833 Relief Valve +3Fuel System, OtherEquipment1104 Aug 2015
15V531000Thor Motor CoachThor Motor Coach Tuscany XTE 2014 +1EquipmentVehicle9819 Aug 2015
15V489000Felling Trailers, IncFelling FT-6T 2016StructureVehicle925 Aug 2015
15V484000Forest River, Inc.Cedar Creek Silver Back 2015 +1EquipmentVehicle914 Aug 2015
15V528000Mack Trucks, Inc.Mack Granite (gu) 2013 +5Service Brakes, AirVehicle8418 Aug 2015
15V539000East Manufacturing Corp.East Manufacturing Frame Genesis Trailer 2016 +20SuspensionVehicle8324 Aug 2015
15V492000Newmar CorporationNewmar Mountain Aire 2016 +4SuspensionVehicle825 Aug 2015
15V521000Mack Trucks, Inc.Mack Pinnacle (cxu) 2014 +2Service Brakes, AirVehicle7917 Aug 2015
15V485000New Flyer Industries Ltd.Nabi 40Lfw 2014 +2Fuel System, OtherVehicle704 Aug 2015
15V522000Mack Trucks, Inc.Mack Granite (gu) 2012 +9Electrical SystemVehicle6217 Aug 2015
15V543000Strick Trailers, LLCStrick Van Trailer 2009 +1StructureVehicle3327 Aug 2015
15V532000Oshkosh CorporationOshkosh S-Series 2015 +1Fuel System, OtherVehicle3320 Aug 2015
15V527000Forest River, Inc.Starcraft Bus All Star XL 2013 +3Electrical SystemVehicle3218 Aug 2015
15V525000Forest River, Inc.Starcraft Bus All Star XL 2013 +2Fuel System, OtherVehicle3018 Aug 2015
15V487000Forest River, Inc.Palomino Palomini 2015Power TrainVehicle235 Aug 2015
15V526000Turtle TopTurtle Top Vanterra 2014 +3Back Over PreventionVehicle1418 Aug 2015
15V511000Pierce ManufacturingPierce Velocity 2014 +3Exterior LightingVehicle1212 Aug 2015
15V544000Corp. Micro Bird Inc.Micro Bird G5 Transit Bus 2013 +2Electrical SystemVehicle1131 Aug 2015
15V535000Strick Trailers, LLCStrick Van Trailer 2014SuspensionVehicle421 Aug 2015
15V494000Turtle TopTurtle Top Odyssey XL MPV 2010 +1Latches/Locks/LinkagesVehicle26 Aug 2015
15V488000Ameritrans Bus, Inc.Ameritrans 225 2015Back Over PreventionVehicle25 Aug 2015

Ordered by units. DND: do-not-drive advisory; PO: park-outside advisory. Campaigns naming several vehicles link to the first; the others are on that vehicle's model page.

CPSC consumer product recalls

DateRecallFirmCategoryHazardUnitsNo.
27 Aug 2015Huffy Recalls Bicycles with Front Disc Brakes to Replace Quick Release Lever Due to Crash HazardHuffyBicycles and Bicycle AccessoriesCrash46015221
27 Aug 2015Tippmann Sports Recalls Paintball Markers Due to Impact Hazard (Recall Alert)Tippmann SportsPaintball Equipment & AccessoriesFire, Impact injury6,50015750
26 Aug 2015Robert Bosch Tool Recalls Dremel Rotary Tool Due to Burn HazardRobert Bosch ToolOther Portable or Stationary Power ToolsBurn, Overheating93,00015227
26 Aug 2015CAMP USA Recalls Tour Nanotech Crampons Due to Fall HazardCAMPMountain ClimbingFall50015226
26 Aug 2015CAMP USA Recalls Blade Runner Crampons Due to Fall HazardCAMPMountain ClimbingFall90015225
26 Aug 2015Trek Recalls Superfly Bicycles Due to Fall Hazard; Seatpost Can Crack and BreakTrek BicycleBicycles and Bicycle AccessoriesFall33015224
25 Aug 2015Cybex International Recalls Arm Curl Machines Due to Impact Injury Hazard (Recall Alert)Cybex InternationalExercise Machines/EquipmentImpact injury4,40015749
25 Aug 2015Osram Sylvania Recalls T8 LED Tubes Due to Burn HazardOsram SylvaniaLight BulbsBurn, Overheating46,30015223
25 Aug 2015Scag Power Equipment Recalls Lawn Mowers Due to Fire HazardScag Power Equipment, a division of Metalcraft of MaryvilleRiding Lawn MowersFire4,40015222
20 Aug 2015Madewell Recalls Women's Sandals Due to Fall HazardMadewellSandals and Flip FlopsFall50,60015220
19 Aug 2015Grizzly Recalls Table Saws Due to Laceration and Impact Hazards (Recall Alert)Grizzly IndustrialBench or Table SawsLaceration, Impact injury1,24015748
18 Aug 2015Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure RequirementMerck Sharp & DohmeTablet or Capsule DrugsPoisoning276,00015219
18 Aug 2015Tvilum Recalls Chairs Sold Exclusively at Copenhagen Imports Due to Fall Hazard (Recall Alert)Copenhagen ImportsChairsFall53015747
18 Aug 2015Rite Aid Recalls Outdoor Dining Sets Due to Fall HazardPatio FurnitureFall13,00015218
18 Aug 2015IKEA Recalls Children’s Nightlight Due to Electrical Shock HazardIKEA North America ServicesNight-LightsElectric shock359,00015217
14 Aug 2015Trane and American Standard Recall Accessory Heaters Due to Fire Hazard (Recall Alert)Trane U.SElectric HeatersFire, Overheating3,90015746
13 Aug 2015J.M. Mattress Recalls Renovated Mattresses Due to Violation of Federal Flammability StandardMattressesFire, Violation of standard24015215
13 Aug 2015American SportWorks Recalls Four-Wheel Off-Road Utility Vehicles Due to Risk of InjuryAmerican SportWorksUtility Vehicles3,50015214
13 Aug 2015Ambient Weather Recalls Weather Radios Due to Fire HazardRadiosFire, Overheating12,50015213
12 Aug 2015Flowers By Zoe Recalls Girls Striped Hoodie and Neon Tie Dye Jacket Due to Strangulation HazardFlowers By Zoe, Melville, NYOuterwearStrangulation12215212
11 Aug 2015Breezer Recalls Downtown Bicycles Due to Crash Hazard; Pedals Can Come OffAdvanced Sports InternationalBicycles and Bicycle AccessoriesCrash1,70015211
6 Aug 2015Viking Range Expands Dishwasher Recall Due to Fire HazardViking RangeDishwashersFire, Overheating17,30015210
6 Aug 2015The Children's Place Recalls Boys' Varsity Jackets Due to Choking HazardOuterwearChoking13,70015209
6 Aug 2015Precious Cargo Recalls Infant One-Piece Garments Due to Choking HazardSanMarClothing (Children)Choking479,00015208
5 Aug 2015Disney Store Recalls Pencil Cases Due to Ingestion Hazard (Recall Alert)Disney StorePens/Pencils & AccessoriesPoisoning30015745
5 Aug 2015MZB Recalls Children's Watches Due to Risk of Skin IrritationMZBWatchesBurn, Lead or chemical1,900,00015207
4 Aug 2015Manhattan Group Recalls Children’s Elephant Activity Toys Due to Choking HazardManhattan GroupDolls or Plush Toys or Action FiguresChoking3,40015206
4 Aug 2015John Deere Recalls Riding Lawn Tractors Due to Crash HazardDeere & CompanyGarden Tractors and AccessoriesCrash1,70015205

FDA food, drug and device enforcement

84 device, 45 food, 24 drug; 105 Class II, 32 Class I, 16 Class III. Ordered by report date.

InitiatedProduct (first record)Recalling firmTypeClassRecords
17 Aug 2015Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.Bausch & Lomb, Inc.DrugClass II1
13 Aug 2015AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50Vintage Pharmaceuticals LLC, DBA Qualitest PharmaceuticalsDrugClass III1
7 Aug 2015IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.International Biophysics Corp.DeviceClass II3
3 Aug 2015Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60 (71906)Individual firm, name withheldDrugClass II1
31 Jul 2015AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.Boston Scientific CorporationDeviceClass II4
31 Jul 2015Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.Siemens Medical Solutions USA, Inc.DeviceClass II3
31 Jul 2015Kraft American Singles Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1 lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and blue lettering.Kraft Heinz FoodsFoodClass II2
31 Jul 2015Classic Caramel Gourmet Popcorn, sold under brand Freedom Snacks, packaged in a flexible plastic bag, net wt. 10 oz.. There is NO UPC. The product is labeled in parts: "***FREEDOM SNACKS***CLASSIC CARAMEL Gourmet Popcorn***Ingredients: popcorn, brown sugar, sugar, corn syrup, butter (cream, salt), soybean oil, soy…Freedom SnacksFoodClass II2
29 Jul 2015Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.Synthes (USA) Products LLCDeviceClass II1
29 Jul 2015Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.Wockhardt Usa Inc.DrugClass II2
28 Jul 2015Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01Fresenius Kabi USA, LLCDrugClass III1
27 Jul 2015Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.Trumpf Medical Systems, Inc.DeviceClass II5
27 Jul 2015Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens…CepheidDeviceClass III2
24 Jul 2015Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.Medtronic Perfusion SystemsDeviceClass II1
24 Jul 2015COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.Boehringer Ingelheim Roxane IncDrugClass II1
24 Jul 2015Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693…Shionogi Inc.DrugClass III1
24 Jul 2015univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01. (71986)Ucb, IncDrugClass II1
23 Jul 2015JAMES FARM GARDEN PEAS CHICHAROS, NET Wt. 40 OZ (2.5 LBS), FRESH FROZEN, UPC 7 60695 01000, product is packed in plastic bags and shipped as 12 units/40 oz. per carton, Net Wt. 30lb. Distributed by RD/Jet, LLC 15-24 132 nd Street College Point, NY 11356. PRODUCT OF POLAND. (71775)Restaurant DepotFoodClass II1
21 Jul 2015Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.CareFusion 303, Inc.DeviceClass I1
20 Jul 2015Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm…TITAN SPINE, LLCDeviceClass II1
20 Jul 20152.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand…Trilliant Surgical Ltd.DeviceClass II1
20 Jul 2015Pride of Africa brand Enriched Farina, Net Weight 5 lb. (2.27 kg), UPC 016712016840 --- Product of The Raymond-Hadley Corp. Spencer, NY 14883 --- Product is packaged in a clear plastic pouch with green, brown and white artwork.Raymond-Hadley Corp.FoodClass II1
17 Jul 2015Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.Advanced Sterilization ProductsDeviceClass II1
17 Jul 2015Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.Medtronic Navigation, Inc.DeviceClass II2
17 Jul 20150.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.Baxter Healthcare Corp.DrugClass I2
17 Jul 2015buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86Sun Pharma Global FzeDrugClass III1
17 Jul 2015FITzee Foods Paleo Turkey Meatloaf all sizes (small, medium, large and XL) (71743)Optimal Nutrition, IncFoodClass II1
16 Jul 2015Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LBFresenius Medical Care Holdings, Inc.DeviceClass II1
16 Jul 2015Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.Otto Bock Healthcare GmbHDeviceClass II1
16 Jul 2015Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for…Radiometer America IncDeviceClass II1
16 Jul 2015Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).Covidien LP (formerly Nellcor Puritan Bennett Inc.)DeviceClass I1
16 Jul 2015Friendly's Vienna Mocha Chunk Ice Cream Tub, 48 U.S. FL. OZ. UPC: 0-29839 00557-4 (71728)Friendly Ice Cream Corp.FoodClass II1
15 Jul 2015EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.Medtronic Cardiovascular Surgery-the Heart Valve DivisionDeviceClass I1
15 Jul 2015biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01GlaxoSmithkline Consmer HealthcareDrugClass II8
14 Jul 2015Biograph mCT S(40)-4R, Model Number 10248671Siemens Medical Solutions USA Inc.DeviceClass II8
14 Jul 2015Danish Rolls, 4 Ct., Net Wt. 13oz. in clear plastic clam shell.Supervalu, Inc.FoodClass I3
14 Jul 2015Raw Frozen Tuna Chunks Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.Osamu CorporationFoodClass I5
14 Jul 2015Dijon Mustard Potato Salad, NET WT 3 LB (1.36 kg)D & D Foods, Inc.FoodClass I1
13 Jul 2015RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. (71714)Individual firm, name withheldDeviceClass II1
13 Jul 2015PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.Draeger Medical, Inc.DeviceClass I1
13 Jul 2015Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37 (71765)Perrigo Israel PharmaceuticalsDrugClass III1
13 Jul 2015Lee Egg Rolls Vegetables and Textured Vegetable Protein, Net Wt. 15lbs. 0 oz., Lee Egg Rolls Jacinto City, Texas 77029 (71700)LV Foods, Incorporated dba Lee Egg RollsFoodClass III1
12 Jul 2015Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is…Etac Supply Center AbDeviceClass II1
10 Jul 2015GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa…GE HealthcareDeviceClass II1
10 Jul 2015A Taste of the East maya brand Cashew Split, packaged and sold in various sizes: (a) Net Wt. 7oz. (198g) UPC 0 20843 23038 9, (b) Net Wt. 14oz. (396g) UPC 0 20843 23071 6, (c) Net Wt. 28oz. (793g) UPC 0 20843 23032 7; (d) NET WT: 5 lbs. (2.25 kg) UPC 0 20843 23030 3 --- Packed and Distributed By: MAYA OVERSEAS FOODS… (71403)Maya Overseas Foods,IncFoodClass I1
9 Jul 2015IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorationsIvoclar Vivadent, Inc.DeviceClass II1
9 Jul 2015Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212Cadence Inc.DeviceClass II2
9 Jul 2015Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PAMutual Pharmaceutical Company, Inc.DrugClass II3
9 Jul 2015Maruchan Instant Lunch Sabor A Pollo, Contenido Neto 64 g, UPC code: 0 41789 00191 8, Maruchan Inc. Irvine, CA 92618. Product is packaged in a styrofoam cup with cardboard label wrapped around.Maruchan, Inc.FoodClass II3
8 Jul 2015Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.Medline Industries IncDeviceClass II1
7 Jul 2015S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.Aesculap, Inc.DeviceClass II1
7 Jul 2015Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.C.R. Bard, Inc.DeviceClass II5
6 Jul 2015DHEA 25mg, 60 count, sku: #6-09492-41001-6, and 90 count, sku: #6-09492-41002-3; 12 bottles/case. (71645)Chemi-source, Inc.FoodClass II1
6 Jul 2015Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Cells***Dietary Supplement 30 SOFTGELS***." (71790)Mason Vitamins, Inc.FoodClass III1
2 Jul 2015Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire…Cook Inc.DeviceClass I3
2 Jul 20150.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.Baxter Healthcare Corp.DrugClass II1
2 Jul 2015Bella Rosa Parmesan Net Wt. 20 oz (567 g) 1.25 LB Arthur Schuman, Inc. Fairfield, NJ 07064 UPC 088231410041 (71637)Arthur Schuman Inc.FoodClass I1
2 Jul 20152 fully baked pizza shells packed in plastic bag with labeling reading: Cowden's Lycoming Bakery 220 Curtain St, South Williamsport, PA; 2 Pizza Shells Net Wt. 20 oz. Ingredients: ***Flour (Hard Spring wheat flour), water, shortening (partially hydrogenated soybean and cottonseed oil), reddisponge (whey, corn flour,… (71686)Cowden's Lycoming BakeryFoodClass II1
2 Jul 2015Vegetable Chili, 8 oz plastic container, labeled with a green and white label with green and white lettering.Brett Anthony FoodsFoodClass I1
1 Jul 2015Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.The Anspach Effort, Inc.DeviceClass II1
1 Jul 20158.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill…Synthes (USA) Products LLCDeviceClass II1
1 Jul 2015Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.Synthes (USA) Products LLCDeviceClass II1
1 Jul 2015Peach Pie 9 Inch NET WT. 2lb 4oz (1021g) and Peach Pie Half NET WT. 1lb 1oz (482g) and individual slicesWhole Food MarketFoodClass I3
30 Jun 2015PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. (71658)BIOTRONIK, Inc.DeviceClass II1
30 Jun 2015PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.Remel IncDeviceClass II2
30 Jun 2015Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.Siemens Medical Solutions USA, IncDeviceClass II1
30 Jun 2015ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.Siemens Healthcare Diagnostics, Inc.DeviceClass II1
30 Jun 2015Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108 (71717)GlaxoSmithkline Consmer HealthcareDrugClass III1
30 Jun 2015IQF Italian Cut Green Beans (each tote 1350 lbs) lot 880804 Harvest Delight Italian Green Beans, (Veg, mixed, FZN, Italian Blend, IQF) 2 lb. poly bags, 12 x 2 lbs, per case Lot 87151056, 960 cases, packed on 4/30/15; Harvest Delight Italian Green Beans, Lot 880271056, 848 cases, packed on 6/9/15; MFG SKU: 10568. (71632)Inn Foods Inc.FoodClass II1
30 Jun 2015Crystal Farms Simply Potatoes Shredded Hash Browns packaged as individual plastic bags Net Wt. 20 oz (1 lb 4 oz) 567 g; UPC 0 20169 22233 4. The 20 oz containers are packed 12 per case (15 lbs total weight); UPC 2 00 20169 22233 8. Distributed by Crystal Farms, Minnetonka, MN.Michael Foods, Inc.FoodClass II1
29 Jun 2015ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.Merit Medical Systems, Inc.DeviceClass II1
29 Jun 2015ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter…Siemens Medical Solutions USA, Inc.DeviceClass II1
29 Jun 2015Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational…Siemens Medical Solutions USA, IncDeviceClass II3
29 Jun 2015OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.Covidien LP (formerly Nellcor Puritan Bennett Inc.)DeviceClass II2
29 Jun 2015RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9 (71716)Consumer Product Distributors Inc. dba J Polep DistributifFoodClass III1
27 Jun 2015goodies by Nature RAW CASHEWS, NET WT. 9 oz (255g), held in clear plastic tubs, UPC code of 846034010055. Distributed By: Grand BK Corp. 47-08 Grand Ave. Maspeth, NY 11378. Product of India. (71588)GRAND BK CORP.FoodClass I1
27 Jun 2015Atkins Chocolate Candies  5 ct. cartons - UPC code 637480075558Atkins Indiana Distribution CenterFoodClass II2
26 Jun 2015Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.Getinge Disinfection AbDeviceClass III1
26 Jun 2015Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.Hardy DiagnosticsDeviceClass II7
26 Jun 2015Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.Ranbaxy Inc.DrugClass II1
26 Jun 2015S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40The Apothecary Shoppe LLCDrugClass II28
26 Jun 2015Free Range Snack Co. Island Fruit and Nut Trail Mix, Net We 16 oz (454g)Rocky Mountain Foods, IncorporatedFoodClass I2
25 Jun 2015Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.Tornier, IncDeviceClass II1
25 Jun 2015ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal,…Siemens Medical Solutions USA, Inc.DeviceClass II1
25 Jun 2015ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative,…Siemens Medical Solutions USA, Inc.DeviceClass II1
25 Jun 2015Whole Foods Market Raw Macadamia Nuts NET WT 11 oz (312g). UPC: 0-76958-62059-1, Distributed by Whole Foods Market Austin, TX 78703Whole Foods MarketFoodClass I1
25 Jun 2015HEB Bake Shop 8 Hamburger, Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 04122041461; HEB Bake Shop 6 Texas Sized Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220742264; Kurz Texas Size Plain Buns (no label)H E B Grocery Company, LPFoodClass II7
24 Jun 2015S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose,…Roche Diagnostics Operations, Inc.DeviceClass II1
24 Jun 2015Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg). Product Usage: The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family…ErgoSafe Products, LLC (DBA) Prism MedicalDeviceClass II2
24 Jun 201518inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for…Zimmer Surgical IncDeviceClass II2
24 Jun 2015FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139Encore Medical, LpDeviceClass II1
24 Jun 2015Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive…Synthes (USA) Products LLCDeviceClass II1
24 Jun 2015rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.Stryker Howmedica Osteonics Corp.DeviceClass II5
24 Jun 2015Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02Teva Pharmaceuticals USADrugClass II1
23 Jun 2015BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.Becton Dickinson & CompanyDeviceClass III1
23 Jun 2015Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.Actavis Laboratories, FL, Inc.DrugClass III1
23 Jun 2015Wish-Bone Ranch Dressing Net. Wt. 24 oz. Distributed by Pinnacle Foods Group USA LLC Cherry Hill, NJ 08003-3620 UPC 0-41321-00661-6Pinnacle Foods, LLCFoodClass I1
22 Jun 2015Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.Draeger Medical, Inc.DeviceClass II1
19 Jun 2015MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.Medtronic MiniMed Inc.DeviceClass II1
19 Jun 2015Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236Atrium Medical CorporationDeviceClass II1
19 Jun 2015Acadia Natural Spring Water, 16.9 Fl Oz, Distributed by FoodHold USA, Inc, Landover, MD 20785; Acadia Natural Spring Water, 8 Fl Oz, Distributed By: FoodHold USA, LLC, Landover, MD 20785; Acme Natural Spring Water, 16.9 Fl Oz., Distributed By Supervalu, inc., Eden Prairie, MN 55344; Blu all natural Spring Water, 16.9… (71557)Niagara Bottling, LLCFoodClass III1
17 Jun 2015Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%,… (71550)Acon Laboratories, Inc.DeviceClass III1
17 Jun 2015Invivo Expression MRI Patient Monitoring System.Philips Electronics North America CorporationDeviceClass II1
16 Jun 2015SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape. (71300)Symmetry Surgical, Inc.DeviceClass II1
16 Jun 2015Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and… (71666)B. Braun Interventional SystemsDeviceClass II1
15 Jun 2015i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.Abbott Point Of Care Inc.DeviceClass II1
12 Jun 2015OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. (71524)Oxysure Systems, Inc.DeviceClass II1
12 Jun 2015PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8. (71480)GC Natural Nutrition, Inc.DrugClass I1
12 Jun 2015Fat Free Pasteurized Prepared Cheese Product: SOUTHHOME 12/12OZ AMERICAN FAT FREE YELLOW, 0788001319. ROUNDYS 12/12OZ AMER FAT FREE YLW, 1115051105. SHUR FINE 12/12OZ AMER FAT FREE YLW, 1116146131. HAGGEN 12/12OZ AMER FAT FREE YLW, 269845607.5 FOODDCLUB 12/12OZ AMER FAT FREE YLW, 368004543.2. EVERYDAY 12/10.7OZ FF…Dairy Farmers OF America IncFoodClass II34
12 Jun 2015Baked Seasoned Sardine Okabe (Asuri Washi Shiokoki) Net Wt.: 70GR/2.47oz SKU: 4 971455 081714 Ingredients: Sardine, Salted Rice Malt, Sugar, Sorbitol, Monosodium Glutamate Keep Refrigerated Exported By: KC Central Trading Co. Ltd. 4F 7-2 Irifune 3-Chome Chuo-Ku Tokyo 104-0042 Japan 03-3552-6906Mitsuwa CorporationFoodClass II3
9 Jun 2015Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.Olympus Scientific Solutions AmericasDeviceClass II1
5 Jun 2015Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic…Philips Electronics North America CorporationDeviceClass II1
4 Jun 2015Gummy Vites Complete Multivitamin L'il Critters 70 gummies Manufactured for Church & Dwight Co., Inc. Ewing, NJ 08628Church & Dwight IncFoodClass II1
3 Jun 2015Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.Elite Biomedical Solutions LLCDeviceClass I2
1 Jun 2015HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.Teleflex MedicalDeviceClass I4
29 May 2015Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial…Stryker Howmedica Osteonics Corp.DeviceClass II1
29 May 2015InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium…Skeletal Kinetics, LlcDeviceClass II1
29 May 2015Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.Stryker Howmedica Osteonics Corp.DeviceClass II1
29 May 2015Walnut bolis (tube), La Jalpita brand, 3.5 fl. oz. No UPC. This product contains artificial flavoring instead of real walnut.Individual firm, name withheldFoodClass I12
27 May 2015Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.Musculoskeletal Transplant Foundation, Inc.DeviceClass II1
27 May 2015Glucosamine 750 mg 120 ct, Capsule, Dosage: 12 capsules, 750 mg ea., three times daily with meals (71664)Novacare, LLCFoodClass II1
22 May 2015American Science & Engineering Inc,Gemini Cabinet X-ray system. (71696)American Science & Engineering, Inc.DeviceClass II1
15 May 2015Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.Veridex, LLCDeviceClass II1
13 May 2015Outer carton : Nabisco Newtons Fig 24-2 OZ (56 g) Packs Net Wt 3 lbs Mondelez International Mondelez Global LLC East Hanover, NJ 07936 USA Made in Mexico case UPC 0 44000 03445 0 Inner Pouch: Nabisco Newtons Fig Net Wt 2 oz (56 g) Mondelez Global LLC, East Hanover, NJ 07936 Made in Mexico retail UPC 0 44000 03445 0Mondelez InternationalFoodClass II1
12 May 2015ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork IrelandStryker Howmedica Osteonics Corp.DeviceClass II1
4 May 2015AMERICA'S BEST CORRIANDER POWDER, NET WT.: 1) 7 OZ, 2) 14 OZ. (400 GMS) and 3) 28 OZ, sealed in plastic bags, Packed by Patel Grocery 5303 4th Ave. Brooklyn, NY 11220 (71817)Patel Grocery CorpFoodClass I1
30 Apr 2015***MaxiFlex (Registered)***Multinutrient Formula***Maximum Joint Support***MedOp, Inc.***Dietary Supplement ***120 Vegetable Capsules***Distributed by MedOp, Inc., Oldsmar, FL 34677***www.medop.com***. (71145)MedOp Health, Inc.FoodClass III1
23 Apr 2015Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.Mylan Institutional LLCDrugClass I1
23 Apr 2015Frozen Jamba, Fruit & Veggie Smoothies, Green Fusion, Green Apple, Mango, Pineapple, Kiwi, Banana, Broccoli and Spinach, Makes 2-8oz Smoothies, Net Wt. 8oz (227.2g), packed in plastic pouches, Distributed by: Rader Farms, Inc.Inventure FoodsFoodClass I65
17 Apr 2015Dry Bream-lesh (Fish), Net Wt. varies - weighed upon sale, product is vacuum packed, Distributed by: Royal Sweet Bakery 119 49 Street Brooklyn, NY 11232, PRODUCT OF RUSSIA (71811)Natar Foods, Inc.FoodClass I1
15 Apr 2015ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are…Alcon Research, Ltd.DeviceClass I1
13 Apr 2015ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.The Anspach Effort, Inc.DeviceClass II34
3 Apr 2015Janka Fully Cooked Apricot Pierogi Ingredients: DOUGH: Blended Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate, Thiamine Mononitrate, Riboflavin), Water, Whole Milk, Eggs, Dried Potatoes (Color and Flavor Protected with Sodium Bisulfate, Citric Acid and BHT), Oleomargarine (Liquid Soybean… (71752)Krusinskis Finest Meat ProductsFoodClass II1
2 Apr 2015Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)Winco Mfg., LLCDeviceClass II13
24 Mar 2015Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.Hamilton Medical, Inc.DeviceClass II1
23 Mar 2015Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in…Mylan Institutional LLCDrugClass I3
18 Mar 2015Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.Mylan Institutional LLCDrugClass I1
18 Mar 2015CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.Mylan Institutional LLCDrugClass I1
6 Mar 2015ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label. ********The List of MAXAM products********************************************** AD Nutritional Support for a Positive Outlook; AFX Nutritional Support for Healthy Cellular Function; ANANDA Nutritional Support for Emotional…James G. Cole, Inc., dba ASN/Maxam NeutraceuticsFoodClass II2
2 Mar 2015***Nice! (Trade Mark)***MARIA BISCUITS {0g TRANS FAT}***NET WT 7 OZ (200g)***Distributed by: Walgreen Co, 200 Wilmot Rd,, Deerfield, IL 60015***Walgreens 100% Satisfaction Guaranteed ***Walgreens.com***@2011 Walgreen CO.***Product of Spain***. (70977)Midlon Foods Inc.FoodClass II1
11 Feb 2015Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.EXP Pharmaceutical Services CorpDeviceClass II42
5 Feb 2015Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.Philips Medical Systems (Cleveland) IncDeviceClass II6
2 Feb 2015Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.Invacare CorporationDeviceClass II1
28 Jan 2015Nut Free Pesto, packaged in a institutional size 28 lbs. and 30 lbs. container, sold under brand Rising Sun Farms, UPC 0 18646 48075 9 (70387)Rising Sun Farms IncFoodClass I1
21 Jan 2015Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.Merge Healthcare, Inc.DeviceClass II1
8 Dec 2014"***SLIM X LEAN HOUR 12+ HOUR ENERGY***PRODUCT ID: ASL-SXL-03***Manufactured for: ASL ANABOLIC SCIENCE LABS WINTER PARK, FL 32789*** (70962)Anabolic Science Labs, LLCFoodClass II1
21 Nov 2014Bronchial Double Lumen Tube Set (Left), SterileTeleflex, Inc.DeviceClass II9
10 Nov 2014GE Optional Laser Centering Device X-ray generator.GE Inspection Technologies, LPDeviceClass II1
24 Jul 2014Tasty Peach Slices, NET WT. 3.87 OZ (110g), UPC 6 949663 601787 -- Product of China --- The product was packed in a clear plastic bottle/jar. --- 12.75 mg sulfites per serving. (68889)Lion Pavilion Ltd.FoodClass I1
15 Jun 2014Paragon Laboratory ManagementMcKesson Technologies, Inc.DeviceClass II1
25 Apr 2014Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal,…Hitachi Medical Systems America IncDeviceClass II1
18 Apr 2014Pint sized glasses with decorative artwork that reads Blue: "Who's Your Candy?!" SKU # 835992 Green: "Eye Candy" SKU # 835993 Red: "Hard on the Outside Sweet on the Inside" SKU # 835991Charles Products IncFoodClass I2
15 Apr 2014RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.Cordis CorporationDeviceClass II1

Questions and answers

How many recalls were there in August 2015?

64 NHTSA vehicle campaigns and 9 equipment, tire or child-seat campaigns, 28 CPSC consumer product recalls and 153 FDA enforcement events (471 product records).

What was the largest vehicle recall in August 2015?

15V519000 by General Motors LLC, about 429,170 units (exterior lighting).

Where does this data come from?

NHTSA flat files (campaigns by the date the Part 573 report was received), the CPSC recall API (by announcement date) and openFDA enforcement reports (by FDA report date), retrieved 24 Sep 2026.

Provenance

Sources: NHTSA Office of Defects Investigation flat files (public domain), CPSC Recall Retrieval Web Services (public domain), openFDA enforcement reports (CC0), retrieved 24 Sep 2026. Months are assigned by report-received date (NHTSA), announcement date (CPSC) and FDA report date. See the methodology.