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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

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2016 American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 30, 2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./... The product lot did not meet sterility requirements based on FDA sampling and analysis. Class II Amd-Ritmed, Inc.
Mar 3, 2016 Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 c... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x ... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 6... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 ... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 ... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Sof... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 8... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 4... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x ... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 ... Compromised sterility due to breach of barrier Class II Covidien LLC
Mar 3, 2016 Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... Compromised sterility due to breach of barrier Class II Covidien LLC
Feb 24, 2016 IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reo... Product does not meet sterility requirements based on FDA analysis and tested positive for Bacter... Class II Amd Ritmed
Feb 10, 2016 Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternat... Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovere... Class II Ambu Inc.
Feb 4, 2016 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with insert... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016 (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting... During an evaluation of the product packaging, it was determined that there is a potential for th... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2016 The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization... Water retention issues. Units with filters that remain wet after the sterilization may compromis... Class II PMBS, LLC
Jan 12, 2016 Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07... Arrow has issued a recall for these products due to potential packaging damage. The sterility of ... Class II Arrow International Inc
Dec 9, 2015 BD Intelliport Medication Management System Sensor The system is indicated... The sterility of the product cannot be assured. This may result in increased risk of infection. Class II Becton Dickinson & Company
Dec 1, 2015 PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy s... Damage to package seals potentially compromising sterility. Class II JosNoe Medical, Inc.
Nov 25, 2015 TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STA... The firm was notified by some of their customers that some of the sealed pouches contain tears co... Class II Abeon Medical Corporation
Nov 25, 2015 TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indica... The firm was notified by some of their customers that some of the sealed pouches contain tears co... Class II Abeon Medical Corporation
Nov 25, 2015 Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile E... The firm was notified by some of their customers that some of the sealed pouches contain tears co... Class II Abeon Medical Corporation
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 13, 2015 Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Steril... Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed ca... Class II STERILMED, INC.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model ... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, Inc.
Oct 21, 2015 CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STE... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Pl... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Gu... Sterility of the product cannot be assured. Class II Civco Medical Instruments Co. Inc.
Oct 21, 2015 LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicat... Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... Class II LeMaitre Vascular, 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.