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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 20, 2012 The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. S... Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missin... Class II Zimmer, Inc.
Sep 19, 2012 Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is d... The firm initiated the product recall because labeling on some of the intermediate boxes of cathe... Class II Cure Medical LLC
Sep 19, 2012 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ... Firm received reports of difficulty in flushing the graft cover of the delivery system during dev... Class II Medtronic Vascular, Inc.
Sep 17, 2012 BariAir Therapy System The BariAir Therapy System is a risk management tre... KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The Bari... Class II KCI USA, Inc.
Sep 15, 2012 Centricity PACS System versions 3.X and higher and 4.X and higher Product Us... There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra... Class II Ge Healthcare It
Sep 14, 2012 Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02... Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because o... Class II Merit Medical Systems, Inc.
Aug 31, 2012 Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usa... Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001... Class II Zimmer, Inc.
Aug 27, 2012 Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser... Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p... Class II Zimmer, Inc.
Aug 23, 2012 Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity... Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... Class II Biomet, Inc.
Aug 23, 2012 Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity... Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... Class II Biomet, Inc.
Aug 22, 2012 S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... Class II DePuy Orthopaedics, Inc.
Aug 21, 2012 Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in life... Class II Covidien LP
Aug 21, 2012 Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures which may result in lif... Class II Covidien LP
Aug 20, 2012 Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation ... Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have disco... Class II Abbott Vascular
Aug 16, 2012 Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... Shipped with incorrect software Class II ZOLL Medical Corporation
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 3, 2012 Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: ... Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXI... Class I Ethicon Endo-Surgery Inc
Jul 26, 2012 Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model numbe... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 26, 2012 Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured b... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 25, 2012 Myocardial Heart Wires Intended for temporary atrial and ventricular pacin... Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C... Class II Oscor, Inc.
Jul 24, 2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... In the recalled lot, the products were not machined according to the production router, a size 52... Class II DePuy Orthopaedics, Inc.
Jul 18, 2012 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle ... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per s... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angl... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 14, 2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012 Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 13, 2012 INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 5, 2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jul 5, 2012 MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jun 25, 2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo ... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The el... Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... Class II Terumo Cardiovascular Systems Corporation
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddl... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class II Philips Healthcare Inc.
Jun 4, 2012 Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal C... The deflector may not move freely on the ventricular catheter. The deflector comes pre-positione... Class II Aesculap, Inc.
Jun 1, 2012 Sysmex XE-2100 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-5000 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, 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.