Recall Register

Recalls in June 2018

NHTSA received 80 vehicle recall campaigns in June 2018. NHTSA also received 13 child seat, tire or equipment campaigns. The NHTSA campaigns have 6,177,670 units in total. 15 CPSC recalls have a recall date in the month, with about 1,960,440 units. FDA enforcement reports of the month have 142 events.

All months

Counts

NHTSA vehicle campaigns
80May 2018: 83
NHTSA child seat, tire and equipment campaigns
13
Units in the NHTSA campaigns
6,177,670
CPSC product recalls
15May 2018: 24
FDA enforcement events
142May 2018: 241

Download all recalls of June 2018 (CSV)

NHTSA

Vehicles, child seats, tires and equipment.

NHTSA recall campaigns that NHTSA received in June 2018, newest first
ReceivedCampaignFirst vehicle or productComponentTypeManufacturerUnits
29 Jun 201818V440000Spartan Gladiator 2018 and 9 moreElectrical SystemVehicleSpartan Motors USA865
29 Jun 201818V441000Suzuki DR-Z400S 2018 and 1 moreExterior LightingVehicleSuzuki Motor of America, Inc.191
29 Jun 201818V442000FCCC XCL 2015 and 3 moreSuspensionVehicleDaimler Trucks North America LLC512
28 Jun 201818E046000Mammoth General Matte Black WheelWheelsEquipmentTurn5, Inc.602
28 Jun 201818V437000Cadillac CT6 2016 and 2 moreChild SeatVehicleGeneral Motors LLC22,043
28 Jun 201818V438000Newmar King Aire 2018 and 10 moreElectrical SystemVehicleNewmar Corporation930
28 Jun 201818V439000BMW X5 2018 and 1 moreSuspensionVehicleBMW of North America, LLC43
27 Jun 201818E049000AC Delco TIE Rod END and 4 moreSteeringEquipmentFederal-Mogul Motorparts LLC26,118
27 Jun 201818V434000Altec Aerial Device 2017 and 3 moreElectrical SystemVehicleAltec Industries Inc.290
27 Jun 201818V435000Altec Aerial Device 2017EquipmentVehicleAltec Industries Inc.153
27 Jun 201818V436000Forest River Wildwood 2017 and 6 moreEquipmentVehicleForest River, Inc.326
26 Jun 201818E047000KME TIP Mounting Lift DeviceEquipmentEquipmentKovatch Mobile Equipment Corp.2
26 Jun 201818E048000TRW Ball JointSteeringEquipmentTRW Automotive Inc310
26 Jun 201818V432000Lexus GS 350 2007 and 22 moreFuel System, GasolineVehicleToyota Motor Engineering & Manufacturing114,998
26 Jun 201818V433000KME Predator 2017 and 4 moreEquipmentVehicleKovatch Mobile Equipment Corp.13
25 Jun 201818V424000Spartan Metrostar 2018 and 19 moreElectrical SystemVehicleSpartan Motors USA1,243
25 Jun 201818V426000Mazda CX-5 2018Air BagsVehicleMazda North American Operations682
25 Jun 201818V428000Forest River Wildwood 2019 and 1 moreElectrical SystemVehicleForest River, Inc.110
25 Jun 201818V429000Keystone Summerland 2019EquipmentVehicleKeystone RV Company20
25 Jun 201818V430000Audi A8 2013 and 5 moreFuel System, GasolineVehicleVolkswagen Group of America, Inc.6,633
22 Jun 201818V427000Audi A4 2006 and 26 moreAir BagsVehicleVolkswagen Group of America, Inc.237,947
21 Jun 201818E044000Ricon K-Series Wheelchair Lift and 1 moreEquipment Adaptive/MobilityEquipmentRicon Corporation4,262
21 Jun 201818E045000Hayes Sway Master Hayes Sway MasterElectrical SystemEquipmentSyncro Corporation1,944
21 Jun 201818T009000Innova Ultra RunnerTiresTireAchieva Rubber Corp.2,900
21 Jun 201818V422000Triple E RV Wonder 2017 and 1 moreElectrical SystemVehicleTriple E Recreational Vehicles9
21 Jun 201818V423000E-One Cyclone II 2017 and 1 moreStructureVehicleE-One Incorporated8
21 Jun 201818V425000Fleetwood Flair 2019 and 1 moreElectrical SystemVehicleREV Recreation Group5
21 Jun 201818V431000BMW X3 2018Exterior LightingVehicleBMW of North America, LLC5
20 Jun 201818E043000ZF Air BAG Control UnitAir BagsEquipmentTRW Automotive Inc3,619,897
20 Jun 201818V418000Gillig LOW Floor 2017 and 17 moreExterior LightingVehicleGillig LLC25,579
20 Jun 201818V420000Bugatti Chiron 2018Air BagsVehicleBugatti2
20 Jun 201818V421000Honda Civic 2018EquipmentVehicleHonda (American Honda Motor Co.)13
19 Jun 201818E042000Robert Bosch HDP5 Fuel Pump FlangeFuel System, GasolineEquipmentRobert Bosch LLC6,493
19 Jun 201818V413000Forest River Prime Time 2019EquipmentVehicleForest River, Inc.435
19 Jun 201818V414000Forest River Prime Time 2017 and 2 moreEquipmentVehicleForest River, Inc.301
19 Jun 201818V415000Thor Motor Coach Compass 2018 and 5 moreElectrical SystemVehicleThor Motor Coach158
19 Jun 201818V416000Indian Scout 2018 and 1 moreService Brakes, HydraulicVehicleIndian Motorcycle Company4,185
18 Jun 201818V412000International HX 2019 and 3 moreFuel System, DieselVehicleNavistar, Inc.19
15 Jun 201818E041000Simard Rear Suspension and 1 moreSuspensionEquipmentSimard Suspensions inc89
15 Jun 201818V401000Nissan Versa 2010 and 2 moreAir BagsVehicleNissan North America, Inc.104,762
15 Jun 201818V402000Mazda Mazda6 2005 and 18 moreDo-not-drive advisoryAir BagsVehicleMazda North American Operations308,591
15 Jun 201818V403000Mazda RX-8 2009 and 1 moreDo-not-drive advisoryAir BagsVehicleMazda North American Operations237
15 Jun 201818V404000Mazda MPV 2005 and 6 moreDo-not-drive advisoryAir BagsVehicleMazda North American Operations4,184
15 Jun 201818V405000Mercedes-Benz GLA 250 2018Child SeatVehicleMercedes-Benz USA, LLC.399
15 Jun 201818V407000Mercedes-Maybach S 560 4MATIC 2018 and 3 moreElectrical SystemVehicleMercedes-Benz USA, LLC.1,701
15 Jun 201818V408000BMW G310 GS 2018 and 2 moreStructureVehicleBMW of North America, LLC2,376
15 Jun 201818V409000Thomas Built Buses SAF-T-Liner EFX 2017 and 1 moreService Brakes, AirVehicleDaimler Trucks North America LLC109
15 Jun 201818V410000Thomas Built Buses SAF-T-Liner EFX 2017 and 1 moreService Brakes, AirVehicleDaimler Trucks North America LLC5
15 Jun 201818V411000Freightliner Cascadia 2018 and 1 moreService Brakes, AirVehicleDaimler Trucks North America LLC18,105
14 Jun 201818E040000Ventline LP Bottle StrapEquipmentEquipmentDexter Ventline and Door2,447
14 Jun 201818V395000Chrysler Pacifica 2018 and 1 moreEquipmentVehicleChrysler (FCA US LLC)240,242
14 Jun 201818V396000Dodge Journey 2018VisibilityVehicleChrysler (FCA US LLC)1,741
14 Jun 201818V397000Chevrolet Volt 2013Hybrid Propulsion SystemVehicleGeneral Motors LLC4,606
14 Jun 201818V398000Ram 3500 2018 and 3 moreBack Over PreventionVehicleChrysler (FCA US LLC)1,837
14 Jun 201818V399000Grand Design Solitude 2018 and 1 moreEquipmentVehicleGrand Design RV, LLC200
14 Jun 201818V400000Chevrolet Malibu 2016 and 2 moreAir BagsVehicleGeneral Motors LLC66
13 Jun 201818V388000Porsche Panamera Turbo S E-Hybrid 2018 and 9 moreSuspensionVehiclePorsche Cars North America, Inc.715
13 Jun 201818V406000Volkswagen Eurovan 2003 and 3 moreAir BagsVehicleVolkswagen Group of America, Inc.2,564
12 Jun 201818V391000Lamborghini Aventador 2012 and 6 moreEngine and Engine CoolingVehicleAutomobili Lamborghini1,700
12 Jun 201818V392000Lincoln Navigator 2018 and 2 moreFuel System, GasolineVehicleFord Motor Company5,645
12 Jun 201818V393000KME Predator Aerial 2018 and 6 moreEquipmentVehicleKovatch Mobile Equipment Corp.12
12 Jun 201818V394000New Flyer XN60 2017 and 13 moreService Brakes, AirVehicleNew Flyer of America Inc.908
11 Jun 201814V428000BMW 325I 2002 and 29 moreDo-not-drive advisoryAir BagsVehicleBMW of North America, LLC574,007
11 Jun 201818V389000Ford F-750 SD 2018 and 1 moreService Brakes, HydraulicVehicleFord Motor Company1,474
11 Jun 201818V390000Ford Edge 2018 and 2 morePower TrainVehicleFord Motor Company25
8 Jun 201818E039000HCI 15 Gloss Black HelmetEquipmentEquipmentDarsan Trading Co.180
8 Jun 201818V385000Thor Motor Coach Freedom Elite 2019 and 6 moreSuspensionVehicleThor Motor Coach691
8 Jun 201818V386000Forest River Wildwood 2019 and 1 moreSuspensionVehicleForest River, Inc.152
8 Jun 201818V387000Newmar Essex 2019 and 7 moreVisibilityVehicleNewmar Corporation77
7 Jun 201818V376000Glaval Bus Legacy 2017 and 17 moreSeat BeltsVehicleForest River, Inc.704
7 Jun 201818V379000Altec Digger Derrick 2016 and 3 moreElectrical SystemVehicleAltec Industries Inc.44
7 Jun 201818V380000Volkswagen Atlas 2018Seat BeltsVehicleVolkswagen Group of America, Inc.54,729
7 Jun 201818V381000Ferrari California 2012 and 2 moreAir BagsVehicleFerrari North America, Inc.1,507
7 Jun 201818V382000Mobility Ventures MV-1 2015 and 1 moreExterior LightingVehicleMobility Ventures LLC977
7 Jun 201818V383000Keystone Cougar 2019 and 1 moreEquipmentVehicleKeystone RV Company5,151
7 Jun 201818V384000Spartan K3 2017 and 7 moreTiresVehicleSpartan Motors USA102
6 Jun 201818V373000Northwood Nash 2019TiresVehicleNorthwood Manufacturing, Inc.9
6 Jun 201818V374000BMW X3 2019 and 1 moreLane DepartureVehicleBMW of North America, LLC51
6 Jun 201818V375000Volkswagen Tiguan 2018 and 1 moreAir BagsVehicleVolkswagen Group of America, Inc.821
6 Jun 201818V377000Utilimaster Aeromaster 1994 and 55 moreSeat BeltsVehicleSpartan Motors USA3,194
5 Jun 201818T008000Continental Conti Coach HA3TiresTireContinental Tire the Americas, LLC.3,917
5 Jun 201818V371000Ducati Supersport 2017 and 1 moreFuel System, GasolineVehicleDucati North America1,462
5 Jun 201818V372000Manac Steel Dropdeck 2016 and 7 moreStructureVehicleManac Inc.9
4 Jun 201818V370000Audi A6 2012 and 30 moreAir BagsVehicleVolkswagen Group of America, Inc.139,249
1 Jun 201818V357000Coachmen Leprechaun 2019 and 3 morePower TrainVehicleForest River, Inc.471
1 Jun 201818V361000Forest River Wildcat 2019TiresVehicleForest River, Inc.31
1 Jun 201818V362000Starcraft RV FW Telluride 2019EquipmentVehicleStarcraft RV51
1 Jun 201818V363000Kia Forte 2010 and 14 moreAir BagsVehicleKia Motors America507,587
1 Jun 201818V364000Jayco Fifth Wheel Seismic 2019 and 10 moreEquipmentVehicleJayco, Inc.612
1 Jun 201818V366000Starcraft Bus Senator II MVP 2019 and 10 moreSuspensionVehicleForest River, Inc.144
1 Jun 201818V367000Ford E-450 2018SuspensionVehicleMORryde International, Inc.904
1 Jun 201818V368000Peterbilt 567 2018 and 23 moreElectronic Stability Control (ESC)VehiclePACCAR Incorporated85,626
1 Jun 201818V369000Volkswagen Passat 2018 and 8 moreDo-not-drive advisoryService Brakes, HydraulicVehicleVolkswagen Group of America, Inc.10,225

A campaign that names 2 or more vehicles has a link to the first vehicle. The page of that vehicle shows the campaign in full.

Recall campaign: One recall in the NHTSA recall file, with one campaign number. A campaign can name many makes, models and model years.

Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.

CPSC

Consumer products.

CPSC recalls with a recall date in June 2018
DateRecallFirmCategoryHazardUnitsCPSC number
29 Jun 2018Helmets R Us Recalls Helmets Due to Risk of Head Injury (Recall Alert)Strategic SportsHead injury9,70018751
29 Jun 2018BRP Recalls All-Terrain Vehicles Due to Fuel Leak and Fire Hazard (Recall Alert)BRP U.SFire13,30018750
26 Jun 2018Baccus Recalls Stanley Workbench LED Light and Power Stations Due to Shock and Electrocution Hazards (Recall Alert)Hairishen Electric (Shenzhen)Electric shock20,00018748
26 Jun 2018Huish Outdoors Recalls Scuba Diving Regulators Due to Drowning HazardHuish Outdoors LLC, dba Oceanic and HollisDrowning4,50018181
20 Jun 2018Werner Recalls Aluminum Ladders Due to Fall HazardWernerFall78,00018179
19 Jun 2018Women's Scarves Recalled by Yangtze Store Due to Violation of Federal Flammability Standard Hazard; Sold Exclusively on Amazon.com (Recall Alert)Jin Bo Si Chou Fu Shi You Xian Gong SiBurn, Violation of standard64018749
12 Jun 2018Ashley Furniture Recalls Floor Lamps Due to Burn Hazard (Recall Alert)DBA Export India PVTBurn90018747
12 Jun 2018Lorex Recalls Three Models of Video Monitors Due to Burn HazardRDI Technology (Shenzhen)Burn, Overheating22,00018177
12 Jun 2018Uttermost Recalls Mirrors, Art and Wall Decor Due to Injury HazardThe UttermostFall17,00018176
12 Jun 2018Ketra Recalls to Inspect Recessed Downlights Due to Electrical Shock HazardKetraElectric shock3,40018175
12 Jun 2018A&I Recalls Tractor Canopies Due To Injury HazardATI Products Inc., a subsidiary of Deere & Company6,20018174
8 Jun 2018Amerisun Recalls to Repair Snow Blowers Due to Injury HazardZhejiang DoBest Power Tools34,60018173
6 Jun 2018Vernier Software & Technology Recalls Circuit Boards Due to Burn Hazard (Recall Alert)Vernier Software & Technology, Beaverton, OreBurn, Overheating4,20018746
6 Jun 2018GE Lighting Recalls LED Tube Lamps Due to Shock and Electrocution Hazards; Sold Exclusively at Lowe's StoresGE LightingElectric shock46,00018170
5 Jun 2018Keyera Energy Recalls to Inspect Propane Gas Due to Fire and Explosion HazardsKeyera EnergyFire, Burn, Explosion1,700,00018172

FDA

Food, drugs and devices.

92 device, 32 food, 18 drug. 114 Class II, 17 Class I, 11 Class III.

FDA enforcement events with a report date in June 2018
InitiatedProduct (first record)Recalling firmTypeClassRecords
14 Jun 2018Kellogg's Honey Smacks, 15.3 oz. and 23 oz.Kellogg CompanyFoodClass I1
12 Jun 2018Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90Name withheldDrugClass III3
12 Jun 2018Melissa's Spicy Edamame: Lightly seasoned with Japanese Chile and Sesame Oil. 7 oz. (1.98g) Keep Refrigerated UPC: 0-45255-14637 6 count and 12 count cases; Ingredients: Soybeans, water Sesame oil, Soy Sauce (soy Beans, Wheat and salt) Rice Wine vinegar, Chaotian chile, pepper, sugar, garlic, sodium glutamate.…World Variety Produce Inc.FoodClass III1
11 Jun 2018Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. Event 80277BioDiagnostic InternationalDrugClass II1
7 Jun 2018Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01Mylan Pharmaceuticals Inc.DrugClass III1
5 Jun 2018HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJPharMEDium Services, LLCDrugClass II1
4 Jun 2018Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL Event 80167HOSPIRA INC, LAKE FORESTDrugClass I1
31 May 2018Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1Apotex Inc.DrugClass II1
31 May 20180.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37ICU Medical IncDrugClass II5
30 May 2018Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900 Event 80208Name withheldDrugClass II1
30 May 2018BISCUIT FOOD Cheese Biscuits, The product comes in a 16.5 oz. (468g), clear plastic package. The product UPC codes 6926145714029 and 6926145712902. Manufacturer: Dongguan Jiayou Food Co., Ltd. Product of China. Event 80223SDQ Trading Inc.FoodClass II1
30 May 2018EconoMax Neopolitan, 4 quarts and 56 ouncesH-E-B GROCERY COMPANY LP DBA HEBFoodClass II15
29 May 2018Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…Siemens Medical Solutions USA, Inc.DeviceClass II1
29 May 2018Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05Pharmaceutical Associates IncDrugClass III1
29 May 2018Milk Chocolate Covered Fudge Bites, 3.75oz, PET Pouch, 12 packages per case Event 80224Morley Candy Makers, Inc.FoodClass II1
29 May 2018Meijer DILL PICKLE FLAVORED CLASSIC CRUNCH POTATO CHIPS***UPC 719283594365***LOT CODE***Shearers Foods, LlcFoodClass I1
29 May 2018Commercial breaders and batters Product B58042 Breader XI- 50 pound bags Product B58915 Breader X1- 40 pound bags Product B29767 Batter Mix X1- 50 pound bags Product B57802 CTFSH BRDR X1 - 25 pound bags Product B91412 MSRM BRDR X1- 40 pound bags Product B97705 Breader X3 - 50 pound bagsNewly Weds Foods IncFoodClass II1
28 May 2018Trader Joe's Artisan Bread - Organic French Baguette; (Brown and Serve) Keep frozen; Product code 53835; 24 x 11.5 oz. (326g) - 24 loaves per case. UPC 0053 8350 Product of Canada Manufactured by Groupe Premiere Moisson Inc., 189 Harwood, Vaudreuil-Dorion, Quebec, Canada Distributed and sold exclusively by Trader…Trader Joes CompanyFoodClass II1
25 May 2018Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90Jubilant Cadista Pharmaceuticals, Inc.DrugClass III1
25 May 2018X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.Shadow Holdings DBA Bocchi LabsDrugClass II4
25 May 2018Baskin Robbins Mint Chocolate ChipDean Foods, Inc.FoodClass II1
25 May 2018WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH PITT, NET WT. 1 LB, and 0.50 LB, PRODUCE OF PAKISTAN, IMPORT BY: GLOBAL COMMODITIES INC. NEW YORK USA,Global Commodities IncFoodClass I1
25 May 2018Herd of Turtles confection milk chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89004 3. UPC of 8 oz: 6 55974 89008 1. The label is read in parts: "***INGREDIENTS: MILK CHOCOLATE 35% (SUGAR, COCOA BUTTER, WHOLE MILK POWDER, EMULSIFIER, SOYA LECITHIN, VANILLA), CARAMEL (SUGAR, CREAM, MILK, CORN SYRUP, COCOA…Name withheldFoodClass III3
24 May 2018Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a…Draeger Medical, Inc.DeviceClass II5
24 May 2018STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1Sun Med, LLCDeviceClass II14
24 May 2018Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102 Event 80187Name withheldDrugClass III1
24 May 2018Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290Allergan, PLC.DrugClass I1
24 May 2018Zoe's Cookies Vegan Tuxedo Fudge, 4 oz. (153 kg) individually wrapped cookie. INGREDIENTS: UNBLEACHED FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, ENZYME, FOLIC ACID), EVAPORATED CANE JUICE, VEGAN WHITE CHOCOLATE CHIPS (NON-BONE CHAR PROCESSED SUGAR, VEGETABLE OIL, COCOA BUTTER, SOY LECITHIN,… Event 80178Dough-To-Go IncFoodClass I1
23 May 2018H-E-B Ode to Olives, Sliced Salad Olives, 10 oz. drained weight per jar/ 6 jars per case (this product is sold by the jar at the store level, not by the case), Best by November 3, 2019. Event 80253Agro Sevilla USAFoodClass II1
23 May 2018simply delicious Divvies SEMI-SWEET PEPPERMINT BARS made to share CHOCOLATE bar BENJAMINT CRUNCH ALL NATURAL NUT & DAIRY FREE NET WT. 2.25 OZ. (63g) Event 80168Divvies LLCFoodClass II1
22 May 2018READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58. Event 80192Medline Industries Inc (Northpoint Services)DrugClass II1
22 May 2018Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, Multiple sizes: 8 oz, 16 oz, 32 oz, 64 oz, 1 gal, 2.5 gals, 5 gals, 55 gallon drum, 8oz clear PVC cylinder bottles, all others heavy-duty polyethylene bottles (except single 55-gallon plastic drum). Event 80161Lake Michigan Distilling Co LLCFoodClass I1
21 May 2018The Most Awesome Chocolate Bar EVER, packaged individually in a 1.5 oz bar. The UPC is 8 55966 00178 9. The label is read in parts: "***Lillie Belle Farms***The Most Awesome Chocolate Bar EVER! ***Ingredients: organic milk and dark chocolate (organic cocoa mass, organic cocoa liquor, organic sugar, organic vanilla,… Event 80166JJBL LLCFoodClass II1
21 May 2018Meijer Dark Chocolate Covered Almonds, 18 ounces, packed in a Clear plastic container, 12 containers per caseMeijer, Inc #816 - Grand River PackagingFoodClass II1
21 May 2018Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ; Distributed by Foodhold USA, LLC, Landover, MD 20785; UPC: 688267009266, BEST BY 03/15/2020 Event 80183Ahold USAFoodClass II1
21 May 2018Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plastic package with UPC 4770049011188.Desly International Corp.FoodClass I2
18 May 2018Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee ArthroplastyZimmer Biomet, Inc.DeviceClass II1
18 May 2018Snak Club Tropical Trail Mix: 16 oz. plastic pouch: Ingredients: Raisins, Peanuts, Pineapple, Papaya, Banana Chips, Coconut Chips and Almonds. UPC: , 0-87076-64462-8 Yogurt Trail Mix contains Raisins, Peanuts, Dates, Yogurt Chips, Cashews and Almonds. New Century Snacks, Commerce, CA.New Century Snacks LLCFoodClass I1
18 May 2018Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz plastic bag. 833-AVL-KRTM www.piouslion.comName withheldFoodClass I2
18 May 2018Terry's Potato Salad, Packaged into the following sized containers: 1. Net Wt. 30 lbs. (13.68kg), Mfg No. 20117, UPC 10032345201177. 2. Net Wt. 5 lbs. (2.27Kg), Mfg. No. 21080, UPC 10032345190808 Keep Refrigerated between 35 - 38 F. MFG by Dawn's Foods, Portage, WI 53901Morski Brands Inc. dba Dawn's Fresh FoodsFoodClass II4
17 May 2018POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857Shoreside Enterprises Inc.DrugClass I2
17 May 2018Ziyad Brand Tahini, 8oz, 16oz, gal, 32oz., packed in glass jars Event 80134Ziyad Brothers Importing, Inc.FoodClass I1
16 May 2018DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Zimmer Biomet, Inc.DeviceClass II13
16 May 2018Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJInopak LtdDrugClass II1
15 May 2018Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with…Draeger Medical Systems, Inc.DeviceClass I2
15 May 2018Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0MBi Distributing Inc. dba MBi NutraceuticalsDrugClass II7
15 May 2018Priano Rosso Pesto Sauce, 6.7oz glass jar Event 80117BLM Products U. VertriebsgesFoodClass I1
14 May 2018Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypassMaquet Cardiopulmonary AgDeviceClass II3
14 May 2018Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOOCryoLife, Inc.DeviceClass II2
11 May 2018Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156Smith & Nephew, Inc.DeviceClass II2
11 May 2018Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF…Olsen MedicalDeviceClass II5
11 May 2018Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.Zimmer Biomet, Inc.DeviceClass II1
11 May 2018Olympus JF-140F duodenoscopes (Model NumberJF-140F)Olympus Corporation of the AmericasDeviceClass II2
10 May 2018XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124Angiodynamics Inc. (Navilyst Medical Inc.)DeviceClass II38
10 May 2018Alfalfa Seeds Event 80070Caudill Sprouting LLCFoodClass I1
8 May 2018Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure…Dynarex CorporationDeviceClass II1
8 May 2018ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with…MEDTECH SASDeviceClass II1
8 May 2018Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood…Baxter Healthcare CorporationDeviceClass II2
8 May 2018Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.Zeiss, Carl IncDeviceClass II1
8 May 2018Sugarfina Sugar Cookies Distributed by Sugarfina, Inc. small candy cube, large candy cube, and 1.0oz. taster packet UPC Code: 840278109414; 840278113725; 840278116580 9495 Santa Monica Blvd., Beverly Hills, CA 90210Sugarfina, LLCFoodClass II1
7 May 2018AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 Event 79992WRP Asia Pacific Sdn BhdDeviceClass II1
7 May 2018Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples…Roche Diabetes Care, Inc.DeviceClass II3
7 May 2018Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC…RIJ Pharmaceutical LLCDrugClass II12
4 May 2018Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.Vascular Solutions, Inc.DeviceClass II1
4 May 2018remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin). Event 80068Name withheldDeviceClass II1
4 May 2018RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.Randox LaboratoriesDeviceClass II1
4 May 2018Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463Stryker GmbHDeviceClass II1
4 May 2018smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)Smith & Nephew, Inc.DeviceClass II1
4 May 2018Sauer - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6The C.F. Sauer CompanyFoodClass II5
3 May 2018P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL…Joerns HealthcareDeviceClass II2
3 May 2018HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…Philips Electronics North America CorporationDeviceClass II1
3 May 2018HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can…Ethicon Endo-Surgery IncDeviceClass II2
3 May 2018CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179Maquet Datascope Corp - Cardiac Assist DivisionDeviceClass I1
2 May 2018MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to…Roche Molecular Systems, Inc.DeviceClass II1
2 May 2018NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.…Fresenius Medical Care Renal Therapies Group, LLCDeviceClass II1
2 May 2018Part #: SAM XT-M, Model: Tactical Black or MilitaryThe Seaberg Company IncDeviceClass II3
2 May 2018Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS…HeartwareDeviceClass I1
1 May 2018Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for…Keystone Dental IncDeviceClass II1
1 May 2018Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.Hobbs Medical, Inc.DeviceClass II1
1 May 2018Heritage Shortbreaad Lemon Infused Ingredients: Enriched flour, pasteurized cream(milk),sugar, salt, pure crystallized ginger, organic ground ginger Mfg. by Heritage Shortbread, Inc. Hilton Head Island, SC 09926 Event 80026Heritage Short Bread, Inc.FoodClass II1
30 Apr 2018IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350Philips Electronics North America CorporationDeviceClass II4
26 Apr 2018Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.Draeger Medical, Inc.DeviceClass II1
24 Apr 2018MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.Medline Industries IncDeviceClass II6
20 Apr 2018SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.Siemens Medical Solutions USA, IncDeviceClass II2
20 Apr 2018LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for…Torax Medical, Inc.DeviceClass II5
19 Apr 2018MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic…MicroAire Surgical Instruments, LLCDeviceClass II1
19 Apr 2018VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP… Event 79898Maquet SASDeviceClass II1
19 Apr 2018Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.Siemens Healthcare Diagnostics, Inc.DeviceClass II2
17 Apr 2018Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided…Gyrus Acmi, IncorporatedDeviceClass II1
15 Apr 2018Driscoll's Blackberries; 6 oz. clamshell container; Keep refrigerated. Product of Mexico Driscoll's Inc. Watsonville, CA 95077 Event 79900Driscoll's Strawberry Associates, Inc.FoodClass III1
13 Apr 2018Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19TriMed Inc.DeviceClass II4
11 Apr 2018The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation…Becton Dickinson & CompanyDeviceClass II3
11 Apr 2018Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000Arrow International IncDeviceClass II76
10 Apr 2018Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By Heinens, Warrensville Hts., OH 44128 UPC 0-36232-01871-1Ohio Hickory Harvest Brand Products Inc.FoodClass II6
9 Apr 2018VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit Event 80012VGI Medical, LLCDeviceClass II1
6 Apr 2018Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011COrthofix, IncDeviceClass II20
3 Apr 2018cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and…Roche Diagnostics CorporationDeviceClass II1
2 Apr 2018Bivona Tracheostomy Tube Tracheostomy TubesSmiths Medical ASD Inc.DeviceClass II1
30 Mar 2018C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.PENTAX of America IncDeviceClass II1
30 Mar 2018Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) IncDeviceClass II3
29 Mar 2018Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.25 oz /12 per case, in mylar metalized bag in gable box,R.A.B. Food Group LLCFoodClass II1
27 Mar 2018ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry SystemsSiemens Healthcare Diagnostics, Inc.DeviceClass II1
23 Mar 2018The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification…BioMerieux SADeviceClass II9
5 Mar 2018Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw SetSynthes (USA) Products LLCDeviceClass II3
5 Mar 2018ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor MarkerTosoh Bioscience IncDeviceClass II35
1 Mar 2018XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082 Event 80158KUIYI INTERNATIONAL INC.FoodClass II1
26 Feb 2018Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery. Event 80024Genesee BioMedical, Inc.DeviceClass II1
13 Feb 2018BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983Becton Dickinson & CompanyDeviceClass II2
30 Jan 2018TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device…Orthofix SrlDeviceClass II1
25 Jan 2018Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer…GE HealthcareDeviceClass II2
19 Jan 2018Restoris MCK Onlay Insert Extractor.Mako Surgical CorporationDeviceClass II1
12 Jan 2018Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.Shimadzu Medical SystemsDeviceClass II1
21 Dec 20173910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.Stryker CorporationDeviceClass II1
21 Dec 2017Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest… Event 80179Quantimetrix CorporationDeviceClass III1
20 Dec 2017Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.Ad-Tech Medical Instrument CorporationDeviceClass II1
19 Dec 2017P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.Paragon 28, Inc.DeviceClass II1
18 Dec 2017ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)Siemens Healthcare Diagnostics, Inc.DeviceClass II2
14 Dec 2017DermaPro Waterproof Silicone Tape, SNS57232Safe N Simple, LLCDeviceClass II1
13 Dec 2017Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)C.R. Bard, Inc.DeviceClass II1
13 Dec 201711-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms Event 80020Name withheldDeviceClass II1
11 Dec 2017Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids.…Medical Action Industries IncDeviceClass II1
8 Dec 2017CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,…Datex-Ohmeda, Inc.DeviceClass II1
4 Dec 2017CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and… Event 80137Cellavision ABDeviceClass II1
28 Nov 2017lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical… Event 80096Alere San Diego Inc. DBA Immunalysis CorporationDeviceClass III1
27 Nov 2017Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.Siemens Healthcare Diagnostics, Inc.DeviceClass II1
21 Nov 2017Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes. Event 78975SANTA JOY ORNAMENT & GIFTWARE CODeviceClass II1
20 Nov 2017Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram),…Invivo CorporationDeviceClass II1
13 Nov 2017VNS Therapy Programmer, Model 3000, v1.0 SystemCyberonics, IncDeviceClass II1
10 Nov 2017CritiCore Automated Urine Output and Temperature MonitorC.R. Bard, Inc.DeviceClass II1
6 Nov 2017Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components…CareFusion 303, Inc.DeviceClass II1
28 Oct 2017fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone. Event 78848Name withheldDeviceClass II1
1 Sep 2017Respire Pink Series EF+ Oral Sleep Apnea Device.Respire MedicalDeviceClass II5
27 Jul 2017Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with…Datascope CorporationDeviceClass II3
28 Oct 201612C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.Ion Beam Applications S.A.DeviceClass II1
16 Sep 201612CIon Beam Applications S.A.DeviceClass II2
7 Aug 2016Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and…Ion Beam Applications S.A.DeviceClass II1
11 Mar 2016Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588Datascope CorporationDeviceClass III3
3 Jul 2015nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images.… Event 78467Name withheldDeviceClass II1
15 Dec 2014nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images.… Event 78460Name withheldDeviceClass II1
17 Sep 2014nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. Event 78466Name withheldDeviceClass II1
12 Sep 2014nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Event 78463Name withheldDeviceClass II1
21 Dec 2012nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of… Event 80162Name withheldDeviceClass II1

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Sources

NHTSA recall file through
29 Sep 2026
Newest CPSC recall on the register
24 Sep 2026
openFDA export date
28 Sep 2026

How the register is made. Data sources and licences.

Questions

Which NHTSA campaign of June 2018 has the most units?
Campaign 18E043000, with 3,619,897 units. NHTSA received the report on 20 Jun 2018.
Which CPSC recall of June 2018 has the most units?
CPSC recall 18172, with about 1,700,000 units. The CPSC title is: Keyera Energy Recalls to Inspect Propane Gas Due to Fire and Explosion Hazards
How many FDA recalls of June 2018 are in Class I?
17 of the 142 FDA enforcement events with a report date in June 2018.
Which date puts a recall in June 2018?
For NHTSA, the date NHTSA received the report. For CPSC, the recall date. For FDA, the first report date of the event.