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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

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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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. Class II AbbVie Inc.
Apr 27, 2017 AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. PEG kits have the potential for one of the following defects: missing components, duplicate compo... Class II AbbVie Inc.
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEE... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Replacement kit for outer shell, Broselow Product U... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-r... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 Liquid Urine Control Level 3 For Professional Use in the quality control m... According to Randox Laboratories an investigation indicates a labelling error for 2 of the test m... Class III Randox Laboratories
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer P... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, ... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... The mask component on various lots of the resuscitation devices have been identified as having th... Class I Vyaire Medical
Apr 26, 2017 Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System... Class I Abbott Vascular
Apr 26, 2017 Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The ... Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Bas... Class II Zimmer Biomet, Inc.
Apr 26, 2017 enGen Track System with TCAutomation Software Version 4.2 A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... Class II Ortho-Clinical Diagnostics
Apr 26, 2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-4... Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport... Class II Stryker Howmedica Osteonics Corp.
Apr 26, 2017 Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50... When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the ... Class II Iba Dosimetry
Apr 25, 2017 MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system th... A system component overheated causing melting of the connector and emission of smoke through the ... Class II Medistim Asa
Apr 25, 2017 Pereyra Ligature Carrier 75 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a pot... Class I Vascular Solutions, Inc.
Apr 25, 2017 Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotatin... A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requ... Class II Zimmer Biomet, Inc.
Apr 25, 2017 StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. ste... StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. Class II Bard Access Systems Inc.
Apr 25, 2017 Assist Bed Rail - 6632 A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could r... Class II Invacare Corporation
Apr 25, 2017 ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu... False susceptible results Class II BioMerieux SA
Apr 25, 2017 Pereyra-Raz Ligature Carrier reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Endoscopic Introducer/Extractor reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Stamey Needle reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 25, 2017 Clarke-Reich Laparoscopic Knot Pusher reprocessing instructions do not provide sufficient detailed information for the cleaning, disinf... Class II Cook Inc.
Apr 24, 2017 UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, ... There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... Class II Beckman Coulter Inc.
Apr 24, 2017 UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... Class II Beckman Coulter Inc.
Apr 24, 2017 Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. Class II Konica Minolta, Inc.
Apr 24, 2017 Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... Class I Respironics California Inc
Apr 24, 2017 Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01... Over-tensioning of the band resulting in damage to the band causing it to rupture Class II OrthoPediatrics Corp
Apr 24, 2017 Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reage... Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of ... Class II Beckman Coulter Inc.
Apr 24, 2017 Brennen Skin Graft Mesher. Surgical instrument designed to expand skin gra... Sterilization validation failure. Class II Molnlycke Health Care, Inc
Apr 23, 2017 Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Su... Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp... Class II Greatbatch Medical
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Acces... Class II Teleflex Medical
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter C... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Cat... Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro... Class II Teleflex Medical

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.