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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,096 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 1, 2014 CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... A pinhole leak identified in the packaging of the recalled product potentially could compromise t... Class II Civco Medical Instruments Inc
Jul 25, 2014 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe ... Unit packages may exhibit open seals which impacts package integrity and potentially product ster... Class II Centurion Medical Products Corporation
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 20, 2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... Class II Stryker Endoscopy
Jun 12, 2014 McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 11, 2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... Lack of Sterility Assurance Class II PIONEER SURGICAL TECHNOLOGY, INC.
Jun 3, 2014 eye-pak 7407 Tray Support Cover REF 8065740745 The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot... Class II Alcon Research, Ltd.
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
May 20, 2014 ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Major Laparotomy Pack , convenience pack include multiple components... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN S... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABS... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOF... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) T... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE W... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.