Recalls in July 2018

NHTSA received 57 vehicle recall campaigns in July 2018. NHTSA also received 23 child seat, tire or equipment campaigns. The NHTSA campaigns have 2,134,545 units in total. 12 CPSC recalls have a recall date in the month, with about 607,540 units. FDA enforcement reports of the month have 130 events.

Counts

NHTSA vehicle campaigns: 57June 2018: 80
NHTSA child seat, tire and equipment campaigns: 23
Units in the NHTSA campaigns: 2,134,545
CPSC product recalls: 12June 2018: 15
FDA enforcement events: 130June 2018: 142

Download all recalls of July 2018 (CSV)

Follow by RSS:All new recalls

NHTSA

Vehicles, child seats, tires and equipment.

NHTSA recall campaigns that NHTSA received in July 2018, newest first
Received	Campaign	First vehicle or product	Component	Type	Manufacturer	Units
31 Jul 2018	18V502000	Alta Redshift MXR 2018 and 2 more	Electrical System	Vehicle	Alta Motors	215
31 Jul 2018	18V503000	Freightliner Business Class M2 2013 and 19 more	Steering	Vehicle	Daimler Trucks North America LLC	1,256
31 Jul 2018	18V504000	Cummins Power Generation Generator SET 2015 and 3 more	Electrical System	Vehicle	Cummins Inc.	921
31 Jul 2018	18V510000	Heartland Sundance XLT TT 2018	Tires	Vehicle	Heartland Recreational Vehicles, LLC	12
30 Jul 2018	18E064000	Pro Comp Steering Knuckle	Steering	Equipment	Tap World Wide LLC	81
30 Jul 2018	18E065000	Pro Comp Extended Thread LUG Nuts	Wheels	Equipment	TAP Worldwide, LLC	2,720
30 Jul 2018	18E066000	Pro Comp Control Arms	Suspension	Equipment	TAP Worldwide, LLC	610
30 Jul 2018	18E067000	G2 Axle & Gear Wheel Spacers	Wheels	Equipment	TAP Worldwide, LLC	376
30 Jul 2018	18E068000	LRG Rims 8-LUG Wheel Center Caps	Wheels	Equipment	TAP Worldwide, LLC	3,619
30 Jul 2018	18E069000	LRG Rims Wheels	Wheels	Equipment	TAP Worldwide, LLC	567
30 Jul 2018	18E070000	G2 Axle & Gear Axle Housing	Power Train	Equipment	TAP Worldwide, LLC	230
30 Jul 2018	18E071000	Pro Comp Pitman Arms	Steering	Equipment	TAP Worldwide, LLC	2,212
30 Jul 2018	18E072000	Rubicon Express Lower Control ARM	Suspension	Equipment	TAP Worldwide, LLC	1,954
30 Jul 2018	18E073000	Pro Comp Pro Runner Monotube Shock	Suspension	Equipment	TAP Worldwide, LLC	2,222
30 Jul 2018	18V498000	Thor Motor Coach ACE 2018	Equipment	Vehicle	Thor Motor Coach	167
30 Jul 2018	18V499000	Keystone Summerland 2019	Equipment	Vehicle	Keystone RV Company	344
30 Jul 2018	18V500000	Forest River Cherokee Wolf PUP 2019	Equipment	Vehicle	Forest River, Inc.	156
30 Jul 2018	18V501000	Towblazer Heritage 2018	Suspension	Vehicle	TowBlazer, Inc.	7
29 Jul 2018	18V497000	Mercedes-Benz Metris 2017 and 1 more	Power Train	Vehicle	Daimler Vans USA, LLC	6
27 Jul 2018	18E062000	PTL Engineering RV Door Latches	Equipment	Equipment	PTL Engineering, Inc	442
27 Jul 2018	18V486000	Ram 2500 2016 and 8 more	Structure	Vehicle	Chrysler (FCA US LLC)	1,149,223
27 Jul 2018	18V495000	Trail King Dolly Trailer 2016 and 2 more	Structure	Vehicle	Trail King Industries, Inc.	46
27 Jul 2018	18V496000	Genesis G80 2018	Air Bags	Vehicle	Hyundai Motor America	3,305
26 Jul 2018	18E063000	Whelen Brake Light	Exterior Lighting	Equipment	Whelen Engineering Co Inc	16,342
26 Jul 2018	18V490000	Prime Time Crusader 2019	Equipment	Vehicle	Forest River, Inc.	7
26 Jul 2018	18V492000	Jeep Cherokee 2019 and 1 more	Power Train	Vehicle	Chrysler (FCA US LLC)	5
26 Jul 2018	18V493000	Chrysler Pacifica 2018	Power Train	Vehicle	Chrysler (FCA US LLC)	61
26 Jul 2018	18V494000	Jeep Cherokee 2018	Power Train	Vehicle	Chrysler (FCA US LLC)	702
25 Jul 2018	18E061000	Rock RUN LP Bottle Ring	Equipment	Equipment	Name withheld	344
25 Jul 2018	18V481000	Glaval Bus Legacy 2017 and 17 more	Seat Belts	Vehicle	Forest River, Inc.	707
24 Jul 2018	18E060000	Syntec S3B Restraint Seats	Seats	Equipment	SynTec Seating Solutions, LLC	235
23 Jul 2018	18V488000	Karma Revero 2018	Visibility	Vehicle	Karma Automotive LLC	50
20 Jul 2018	18E058000	Meritor Wheel Stud	Wheels	Equipment	Meritor, Inc.	3,300
20 Jul 2018	18E059000	Jost International Outboard Slider	Trailer Hitches	Equipment	Jost International, Inc.	194
20 Jul 2018	18V472000	Van-CON 33803 Dual Rear-Wheel 2017 and 7 more	Seats	Vehicle	Van-Con, Inc.	1,376
20 Jul 2018	18V487000	Freightliner Business Class M2 2019 and 1 more	Steering	Vehicle	Daimler Trucks North America LLC	9,093
20 Jul 2018	18V489000	Braunability Dodge Wheelchair van 2012 and 13 more	Electronic Stability Control (ESC)	Vehicle	Braun Corporation	31,303
20 Jul 2018	18V491000	Freightliner Cascadia 2019 and 2 more	Electrical System	Vehicle	Daimler Trucks North America LLC	43,584
19 Jul 2018	18V480000	Ducati Panigale V4 2018 and 3 more	Service Brakes, Hydraulic	Vehicle	Ducati North America	72
19 Jul 2018	18V482000	Thor Motor Coach Outlaw 2019 and 1 more	Visibility	Vehicle	Thor Motor Coach	119
19 Jul 2018	18V483000	Yamaha MT-07 2018 and 1 more	Power Train	Vehicle	Yamaha Motor Corporation, USA	3,493
19 Jul 2018	18V484000	GEM Elxd 2016 and 7 more	Electrical System	Vehicle	Polaris Industries, Inc.	2,110
19 Jul 2018	18V485000	GEM EL 2014 and 17 more	Structure	Vehicle	Polaris Industries, Inc.	1,946
18 Jul 2018	18E057000	Brembo Rear Brake Pads	Service Brakes, Hydraulic	Equipment	Brembo S.p.A.	3,026
18 Jul 2018	18V474000	Micro Bird T-Series School Bus 2016 and 23 more	Seats	Vehicle	Corp. Micro Bird Inc.	1,357
18 Jul 2018	18V475000	Forest River Flagstaff 2019 and 3 more	Suspension	Vehicle	Forest River, Inc.	164
18 Jul 2018	18V478000	Freightliner Cascadia 2019	Tires	Vehicle	Daimler Trucks North America LLC	10
18 Jul 2018	18V479000	Freightliner Cascadia 2019	Tires	Vehicle	Daimler Trucks North America LLC	425
17 Jul 2018	18E055000	Industrias Martinrea Brake Hose	Service Brakes, Hydraulic	Equipment	Industrias Martinrea de Mexico SA de CV	3,931
17 Jul 2018	18E056000	CE White School Bus Seat	Seats	Equipment	Hickory Springs Manufacturing Company	31,990
17 Jul 2018	18V473000	BMW M5 2018	Fuel System, Gasoline	Vehicle	BMW of North America, LLC	1,645
16 Jul 2018	18E054000	TRW Brake Caliper Assembly	Service Brakes, Hydraulic	Equipment	TRW Automotive Inc	179,179
16 Jul 2018	18V470000	Ford F53 2018	Wheels	Vehicle	Ford Motor Company	162
16 Jul 2018	18V471000	Ford Fusion 2013 and 5 more	Power Train	Vehicle	Ford Motor Company	504,182
13 Jul 2018	18V467000	Volkswagen Tiguan 2018	Visibility	Vehicle	Volkswagen Group of America, Inc.	45,457
13 Jul 2018	18V468000	Forest River Palomino 2019	Equipment	Vehicle	Forest River, Inc.	38
13 Jul 2018	18V469000	Dutchmen Aerolite 2019 and 1 more	Equipment	Vehicle	Keystone RV Company	126
12 Jul 2018	18E053000	Chrysler 300 2015 and 10 more	Power Train	Equipment	Chrysler (FCA US LLC)	1,930
12 Jul 2018	18V466000	Multiquip TRLR45H 2018 and 1 more	Structure	Vehicle	Multiquip, Inc.	13
11 Jul 2018	18V460000	Jayco Travel Trailer Octane 2018	Equipment	Vehicle	Jayco, Inc.	62
11 Jul 2018	18V461000	Lamborghini Aventador 2015 and 3 more	Wheels	Vehicle	Automobili Lamborghini	8
11 Jul 2018	18V462000	KZRV Sportsmen 2018 and 1 more	Equipment	Vehicle	KZRV, L.P.	500
11 Jul 2018	18V463000	Pierce Quantum 2011 and 54 more	Structure	Vehicle	Pierce Manufacturing	17
11 Jul 2018	18V464000	Volkswagen Golf 2015 and 7 more	Electrical System	Vehicle	Volkswagen Group of America, Inc.	33,168
11 Jul 2018	18V465000	MINI JCW 2019 and 19 more	Engine and Engine Cooling	Vehicle	BMW of North America, LLC	5,309
10 Jul 2018	18E052000	Badass Trooper	Equipment	Equipment	Badass Helmet Company	762
10 Jul 2018	18V455000	Subaru Forester 2018	Equipment	Vehicle	Subaru of America, Inc.	3,654
10 Jul 2018	18V456000	Mercedes-Benz AMG C43 2018 and 7 more	Structure	Vehicle	Mercedes-Benz USA, LLC.	10,826
10 Jul 2018	18V457000	Mercedes-Benz AMG G65 2017	Electrical System	Vehicle	Mercedes-Benz USA, LLC.	20
10 Jul 2018	18V458000	MV Agusta Brutale 800 Dragster RC 2018 and 2 moreDo-not-drive advisory	Suspension	Vehicle	MV Agusta USA, LLC	22
6 Jul 2018	18V452000	Nissan Versa 2007 and 1 more	Air Bags	Vehicle	Nissan North America, Inc.	233
6 Jul 2018	18V453000	BMW X4 2019 and 2 more	Service Brakes, Hydraulic	Vehicle	BMW of North America, LLC	5,594
5 Jul 2018	18V445000	Jayco Precept 2019 and 1 more	Visibility	Vehicle	Jayco, Inc.	124
5 Jul 2018	18V446000	Entegra Emblem 2019 and 1 more	Visibility	Vehicle	Entegra Coach	49
5 Jul 2018	18V448000	Dutchmen Aerolite 2018 and 1 more	Equipment	Vehicle	Keystone RV Company	83
5 Jul 2018	18V449000	Jayco Travel Trailer White Hawk 2019	Equipment	Vehicle	Jayco, Inc.	202
5 Jul 2018	18V450000	Entegra Aspire 2019 and 11 more	Wheels	Vehicle	Entegra Coach	58
5 Jul 2018	18V451000	Jayco Precept 2019 and 9 more	Equipment	Vehicle	Jayco, Inc.	49
3 Jul 2018	18V444000	Coachmen Freelander 2016 and 11 more	Visibility	Vehicle	Forest River, Inc.	53
2 Jul 2018	18E050000	LCI Solera Smart ARM Awning	Equipment	Equipment	Lippert Components, Inc.	14,383

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 July 2018
Date	Recall	Firm	Hazard	Units	CPSC number
31 Jul 2018	Additional Incidents Prompt Johnson Health Tech to Reannounce Recall of Matrix Fitness Ascent Trainers and Ellipticals Due to Fire Hazard (Recall Alert)	Johnson Health Tech North America	Fire	3,000	18755
27 Jul 2018	Hirsch Gift Recalls Wireless Charging Pads Due to Burn Hazard		Burn, Overheating	21,000	18195
26 Jul 2018	Jimmy Hack Golf Recalls Golf Swing Trainers Due to Injury Hazard	Jimmy Hack Golf		6,100	18194
26 Jul 2018	Trek Recalls Bontrager Line Pro Bicycle Pedals Due to Fall Hazard	Trek Bicycle	Fall	9,630	18193
24 Jul 2018	JCPenney Recalls Okie Dokie Denim Patches Shortie Shorts Due to Choking Hazard	J.C. Penney	Choking	5,400	18192
24 Jul 2018	Ross Stores Recalls Bistro Chairs Due to Fall Hazard	Fujian Anxi Shangqing Huaxing Handicraft	Fall	2,300	18190
18 Jul 2018	Crate and Barrel Recalls Mirrors Due to Laceration Hazard (Recall Alert)	LAR Collection	Laceration, Fall	830	18754
12 Jul 2018	Allura Recalls Children's Sleepwear Due to Violation of Federal Flammability Standard	Allura Imports	Burn, Violation of standard	64,000	18188
11 Jul 2018	Burton Recalls Snowboard Boots Due to Fall Hazard (Recall Alert)	Jia You Plastics	Fall	4,800	18753
10 Jul 2018	ORTOVOX Recalls Avalanche Transceivers Due to Loss of Emergency Communications Capability	Ortovox		20,000	18185
6 Jul 2018	Camso Recalls Dirt to Snow Bike Conversion Kits Due to Crash and Impact Hazards	Camso	Impact injury, Crash	480	18184
6 Jul 2018	Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements	Sandoz	Poisoning	470,000	18183

FDA

Food, drugs and devices.

82 device, 25 food, 23 drug. 108 Class II, 12 Class I, 10 Class III.

FDA enforcement events with a report date in July 2018
Initiated	Product (first record)	Recalling firm	Type	Class	Records
13 Jul 2018	Odwalla Superfood fruit smoothie 15.2 oz. (450mL) plastic bottle; Sold in 8 pack case Unit UPC: 000-14054-06405-5 Odwalla Life Food- Canada only - Unit UPC: 000-14054-03125-5 Ingredients: Apple Juice from concentrate, peach and mango purees from concentrate, banana puree, less than 1% OF, Spirulina, natural flavors,…	The Coca-Cola Company	Food	Class II	1
9 Jul 2018	Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01	Mylan Pharmaceuticals Inc.	Drug	Class III	1
6 Jul 2018	Earthrise Natural Spirulina; Net Weight: 20.0 kg( 44.0 lbs); Double bag sealed - 1 bag per box. UPC: 0 32602 99040 3 Event 80468	Earthrise Nutritionals Llc	Food	Class II	1
5 Jul 2018	Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00	Sanofi-Aventis U.S. LLC	Drug	Class II	1
5 Jul 2018	alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.	The Hain Celestial Group, Inc. - Worldwide HQ	Drug	Class II	1
5 Jul 2018	Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.	Teva Pharmaceuticals USA	Drug	Class II	1
3 Jul 2018	Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02	Sun Pharmaceutical Industries, Inc.	Drug	Class II	1
3 Jul 2018	Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007 Event 80453	Medi-Fare Drug and Home Health Center	Drug	Class II	1
3 Jul 2018	Monsel'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 80309	Medgyn Products, Inc.	Drug	Class II	1
2 Jul 2018	Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30	AuroMedics Pharma LLC	Drug	Class I	1
2 Jul 2018	Naked Bread Hamburger Buns #NothingToHide, 8 pack. Product is packaged in low density polyethylene bag and identified as Naked Bread Hamburger Buns #NothingToHide, Net wt. 16.5 oz., UPC #72220 11075. The label is read in parts: "***INGREDIENTS: ENRICHED UNBLEACHED WHEAT FLOUR (WHEAT FLOUR, MALTED BARLEY FLOUR,… Event 80435	United States Bakery Corp	Food	Class I	1
29 Jun 2018	RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for treatment planning and analysis of…	RAYSEARCH LABORATORIES AB	Device	Class II	1
29 Jun 2018	Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059	SCA Pharmaceuticals	Drug	Class II	1
29 Jun 2018	Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.	Fagron Compounding Services LLC dba Fagron Sterile Services	Drug	Class I	2
28 Jun 2018	Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11 Event 80377	Name withheld	Drug	Class II	1
28 Jun 2018	Wish Bone House Italian Salad Dressing 15 oz. Event 80405	Pinnacle Food Group, Llc	Food	Class I	1
27 Jun 2018	Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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…	Ion Beam Applications S.A.	Device	Class II	1
25 Jun 2018	Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]	AMERICAN HEALTH PACKAGING	Drug	Class III	1
25 Jun 2018	Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500	La Vita Compounding Pharmacy, LLC	Drug	Class II	3
22 Jun 2018	Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.	Akorn, Inc.	Drug	Class II	1
22 Jun 2018	eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9 Event 80359	Eb5 Corporation	Drug	Class II	1
22 Jun 2018	Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles with a plastic cap, Net Wt. 17 ounces (502.8 ml). UPC code on bottle: 0 16571 95084 2. UPC on Single Pack Wrapper (1 flavor/12 bottles): 016571953126 UPC on Single Pack Wrapper (1 flavor/24 bottles): NONE… Event 80367	Talking Rain Beverage Co Inc	Food	Class II	1
22 Jun 2018	Brew Dr. Kombucha Clear Mind, item Code: FCG0002, 6 glass bottles per case, net volume: 32 FL OZ (946 ML). UPC: 51107 00369. The bottle's label is read in parts: "*CLEAR MIND*INGREDIENTS: Brewed tea (filtered water, organic green tea, organic rosemary, organic peppermint, organic sage, organic dandelion root),… Event 80362	Name withheld	Food	Class II	1
21 Jun 2018	Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	Device	Class II	6
21 Jun 2018	Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing,…	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	Device	Class II	4
21 Jun 2018	Honey Mama's Oregon Peppermint Cacao-Nectar Bar wrapped in quilon parchment paper with a sticker label. Net wt. 2.5 oz, 3" x 3" bar, 12 bars to a cardboard display case and 12 display cases to a cardboard master case. UPC on each bar is 8 54835 00402 9. The product label is read in parts: "***Paleo HONEY… Event 80361	Nectar Foods LLC	Food	Class I	1
21 Jun 2018	Blue Bell Ice Cream, Brand Homemade Vanilla Flavored, 3 FL OZ (88 mL), Cups, 24 per box, This Unit Not Labeled For Retail Sale	Blue Bell Creameries, L.P.	Food	Class III	1
20 Jun 2018	fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.	Advanced Pharma Inc.	Drug	Class II	1
20 Jun 2018	Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com	Gaia Ethnobotanical LLC	Drug	Class I	24
20 Jun 2018	Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068 Event 80373	Icelandic Provisions Inc.	Food	Class II	1
19 Jun 2018	Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.	Wockhardt Limited	Drug	Class III	2
19 Jun 2018	DRY ROASTED MEDIUM CHOP PEANUT GRANULES NET WT 30LBS (13.61 KGS) Peanut Processors of Sherman Hwy 87 & Albert Street, Dublin, NC 28332	Peanut Processors, Inc.	Food	Class I	2
18 Jun 2018	Hitachi Oasis MRI system Product Usage: Hitachi 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, sagittal, oblique, and curved…	Hitachi Medical Systems America Inc	Device	Class II	1
15 Jun 2018	Del Monte 6 oz. Veg Tray w/dip; Del Monte 12 oz. Veg Tray w/dip contains baby carrots, broccoli, cauliflower and dill dip	Del Monte Fresh Produce N.A., Inc. HQ	Food	Class II	2
14 Jun 2018	VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a… Event 80452	Maquet SAS	Device	Class II	1
14 Jun 2018	Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT	SCA Pharmaceuticals, LLC	Drug	Class II	12
14 Jun 2018	McEvoy Ranch 100% Certified Extra VirginOlive Oil; Made in California; 1 L, 33,8 FL OZ UPC 6 34832 00291 Event 80342	McEvoy of Marin, LLC.	Food	Class III	1
13 Jun 2018	Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716 Event 80266	Name withheld	Drug	Class III	1
12 Jun 2018	Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors	Teleflex Medical Europe Ltd	Device	Class II	1
12 Jun 2018	0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02	Avella of Deer Valley, Inc. Store 38	Drug	Class II	38
11 Jun 2018	MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.	Canadian Hospital Specialties	Device	Class II	1
11 Jun 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.	Cardinal Health 200, LLC	Device	Class II	11
11 Jun 2018	Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm	Edwards Lifesciences, LLC	Device	Class II	1
11 Jun 2018	Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 00443 88822 6 Event 80241	Absonutrix	Food	Class III	1
11 Jun 2018	FUNKTIONAL FOODS brand SPIRULINA POWDER, NET WEIGHT 3.5 oz (100 g) with UPC Code: 060427570192	The TJX Companies, Inc.	Food	Class II	1
8 Jun 2018	ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01	Qualgen, LLC	Drug	Class III	2
8 Jun 2018	Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.	Ingenus Pharmaceuticals Llc	Drug	Class II	2
8 Jun 2018	Al Reef dried apricot sour, 12 oz., packed in plastic, 24 packages per case Event 80278	Golden Star Wholesale Inc	Food	Class I	1
8 Jun 2018	TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 10599 6, 7.5 Lbs. (3 x 2.5 Lbs. Bags), Best Kept Between 34°F and 40°F <50% Relative Humidity Event 80314	T R Toppers, Inc.	Food	Class II	1
8 Jun 2018	WATERMELON CHUNKS 6/9.5Z, 9.5 oz., UPC: 81851301386; WATERMELON SPEAR 6/16Z, 16 oz., UPC: 81851301591; WATERMELON SPEAR 4/28Z, 28 oz.; UPC: 81851301607; WATERMELON CHUNKS 1/5LB, 80 oz., UPC: 81851302147; WATERMELON TRAY 1/5LB, 80 oz., UPC: 81851302239; WATERMELON CHUNK 4/18Z, 18 oz., UPC: 826766260317, Clear Generic…	Caito Foods Service, Inc.	Food	Class I	26
6 Jun 2018	Single Chamber Temporary External Pacemaker, Model 53401	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	Device	Class II	1
4 Jun 2018	Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver 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…	Fx Solutions	Device	Class II	2
4 Jun 2018	26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550	B. Braun Medical, Inc.	Device	Class II	1
4 Jun 2018	BLUEBERRY PRETZEL, NET WEIGHT : 4OZ (113g) ,USE BY DATE : 12/1/2018 Event 80268	Name withheld	Food	Class II	1
4 Jun 2018	Pacific Brand Charcoal Grilled Eel. Premium Quality Unagi Kabayaki UPC: 692156201099 Event 80228	Supreme Foods	Food	Class III	1
30 May 2018	Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40	Zimmer Biomet, Inc.	Device	Class II	15
29 May 2018	Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope	Zeiss, Carl Inc	Device	Class II	1
25 May 2018	GE Healthcare CARESCAPE Monitor B650	GE Healthcare Finland Oy	Device	Class II	1
25 May 2018	Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A…	Name withheld	Device	Class II	2
24 May 2018	FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used…	Fort Defiance Industries, LLC	Device	Class II	1
24 May 2018	Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.	Zimmer Biomet, Inc.	Device	Class II	1
23 May 2018	Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in…	Steris Corporation	Device	Class II	1
23 May 2018	Honey Oat Bran Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10954 9	New Seasons Market LLC	Food	Class I	6
22 May 2018	Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682	Randox Laboratories Ltd.	Device	Class II	3
22 May 2018	UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S	NewDeal SA	Device	Class II	5
22 May 2018	LFIT Anatomic CoCr Femoral Heads, 6260-9-036	Howmedica Osteonics Corp.	Device	Class II	8
22 May 2018	Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT	Name withheld	Device	Class II	14
21 May 2018	Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011…	Philips Medical Systems (Cleveland) Inc	Device	Class II	1
20 May 2018	Belly Fat Reducer + Energy Booster and Stamina, Dietary Supplement	Nutreglo Products, LLC.	Food	Class II	2
18 May 2018	REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60	Implant Direct Sybron Manufacturing, LLC	Device	Class II	1
18 May 2018	Black Bean Cereal Latte; 28.2 oz. package Ingredients: Non Dairy Creamer (corn syrup, vegetable oil, Sodium Caseinate, Silicon dioxide), Rice Powder, Bean Powder, Silicon dioxide, Refined Salt, Black Sesame. Corn syrup 57% Hydrogenated coconut oil 28% Sweet whey powder 10% (the firm said this is 100% pure whey/milk…	Hee Chang Dairy & Food Co., LTD	Food	Class I	4
17 May 2018	VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is…	Arrow International Inc	Device	Class II	4
16 May 2018	Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.	Ion Beam Applications S.A.	Device	Class II	1
15 May 2018	Frozen Natural Tilapia + Belly V-Pack, Farm Raised Tilapia, Product of Costa Rica, Packed for Osamu Corporation Carson, California 90810 Event 80129	R F A Inc.	Food	Class II	1
14 May 2018	AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture… Event 80301	Opgen Inc	Device	Class II	1
14 May 2018	Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery Event 80311	Name withheld	Device	Class II	1
11 May 2018	Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.	Arrow International Inc	Device	Class II	1
10 May 2018	Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a… Event 80291	Anika Therapeutics, Inc.	Device	Class II	1
10 May 2018	microTargeting" Drive System, Product Number MT-DS	FHC, Inc.	Device	Class II	15
9 May 2018	VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic	Ortho-Clinical Diagnostics	Device	Class II	1
9 May 2018	Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions.…	B. Braun Medical, Inc.	Device	Class II	1
9 May 2018	CS-7, Model No. A4C1	Konica Minolta Medical Imaging USA, Inc.	Device	Class II	2
8 May 2018	MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges. Event 80392	Wescam Inc	Device	Class II	1
8 May 2018	Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can…	Stryker Sustainability Solutions	Device	Class II	1
7 May 2018	PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031	Ethicon, Inc.	Device	Class II	19
2 May 2018	Utz Restaurant Style Tortilla Chips; Net Wt 17 oz; White Corn Tortilla Chips; UPC: 0-41780-00383-6; Exp. Date Jun 16 18; UTZ Quality Foods, Inc., Hanover, PA 17331; Utz Restaurant Style Tortilla Chips; Net Wt 11.5 oz; White Corn Tortilla Chips; UPC: 0-41780-00384-3; Exp date Jun 16 18; UTZ Quality Foods, Inc.,…	Utz Quality Food Inc	Food	Class I	6
1 May 2018	OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028	Philips Medical Systems Nederlands	Device	Class II	2
1 May 2018	ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000	Siemens Medical Solutions USA, Inc	Device	Class II	1
1 May 2018	Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.	Siemens Medical Solutions USA, Inc	Device	Class II	12
27 Apr 2018	Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S	Stryker GmbH	Device	Class II	16
27 Apr 2018	Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The…	Roche Diagnostics Corporation	Device	Class II	2
26 Apr 2018	ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.	Horiba Instruments, Inc dba Horiba Medical	Device	Class II	1
25 Apr 2018	Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000	Intersurgical Inc	Device	Class II	1
24 Apr 2018	Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754	Medtronic Inc.	Device	Class II	1
24 Apr 2018	Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S	Biocare Medical, LLC	Device	Class II	1
23 Apr 2018	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.	Tandem Diabetes Care Inc	Device	Class II	1
23 Apr 2018	da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.	Intuitive Surgical, Inc.	Device	Class II	2
17 Apr 2018	Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 Event 80300	Exsurco Medical	Device	Class II	1
16 Apr 2018	Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542,…	St Jude Medical Inc.	Device	Class II	12
16 Apr 2018	St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are…	St Jude Medical Inc.	Device	Class II	2
9 Apr 2018	Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135	Terumo Medical Corp	Device	Class II	1
9 Apr 2018	HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization	Cenorin, LLC	Device	Class II	1
9 Apr 2018	VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH)…	BioMerieux SA	Device	Class II	1
2 Apr 2018	AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a…	AESDEX	Device	Class II	2
2 Apr 2018	T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise…	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device	Class II	1
30 Mar 2018	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus…	Immuno-Mycologics, Inc	Device	Class II	1
29 Mar 2018	Discovery IGS 730 Interventional Fluoroscopic X-ray Systems	GE Medical Systems, SCS	Device	Class II	3
29 Mar 2018	Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in…	Stryker Sustainability Solutions	Device	Class II	1
28 Mar 2018	RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…	RAYSEARCH LABORATORIES AB	Device	Class II	1
28 Mar 2018	Brilliance Big Bore Radiology 728244	Philips Medical Systems (Cleveland) Inc	Device	Class II	5
27 Mar 2018	Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile	Trilliant Surgical Ltd.	Device	Class II	2
23 Mar 2018	Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase…	Medtronic Navigation, Inc.	Device	Class II	1
21 Mar 2018	Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205	Siemens Healthcare Diagnostics, Inc.	Device	Class II	3
15 Mar 2018	LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.	Covidien LLC	Device	Class II	1
12 Mar 2018	Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.	Ohio Medical Corporation	Device	Class II	1
7 Mar 2018	da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors,…	Intuitive Surgical, Inc.	Device	Class II	1
20 Feb 2018	Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery…	Cardinal Health 200, LLC	Device	Class II	4
2 Feb 2018	PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.	Dako North America Inc.	Device	Class II	1
22 Jan 2018	Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral… Event 80069	Valeris Medical, LLC	Device	Class II	1
12 Jan 2018	BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.	Medline Industries, Inc.	Device	Class II	1
4 Jan 2018	Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.	Toshiba American Medical Systems Inc	Device	Class II	1
4 Jan 2018	BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system…	bioMerieux, Inc.	Device	Class II	2
6 Dec 2017	Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health…	Intel-GE Care Innovations LLC	Device	Class II	1
29 Nov 2017	BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR,…	Smiths Medical ASD Inc.	Device	Class II	1
22 Nov 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required…	ECOLAB INC	Device	Class III	2
20 Oct 2016	NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test Event 80110	Ekla Corporation	Device	Class II	1
11 Apr 2016	The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)	Ion Beam Applications S.A.	Device	Class II	1
11 Jul 2013	AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.	Cayenne Medical Inc.	Device	Class II	1
27 Dec 2012	SNI Nitric Blast Sour Apple 276gr (UPC ending in 5581) --- The product is a powder marketed in a 276gr black bottle with a silver cap. The bottle prominently displays the product name "NITRIC BLAST" in silver and white letters on the front of a black label.	Sni llc	Food	Class II	2
18 Jun 2012	Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807	Safe N Simple, LLC	Device	Class II	1

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 July 2018 has the most units?: Campaign 18V486000, with 1,149,223 units. NHTSA received the report on 27 Jul 2018.
Which CPSC recall of July 2018 has the most units?: CPSC recall 18183, with about 470,000 units. The CPSC title is: Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
How many FDA recalls of July 2018 are in Class I?: 12 of the 130 FDA enforcement events with a report date in July 2018.
Which date puts a recall in July 2018?: For NHTSA, the date NHTSA received the report. For CPSC, the recall date. For FDA, the first report date of the event.