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Vehicle Safety

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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 m... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, ... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, ... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diame... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 14, 2012 Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, ... All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... Class II Zimmer, Inc.
Nov 7, 2012 Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Oct 26, 2012 Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... Class II Hospira Inc.
Oct 15, 2012 The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... Class II Ossur Americas, Inc.
Oct 10, 2012 MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ce... A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 ... Class II Siemens Medical Solutions USA, Inc
Sep 28, 2012 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #)... ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip ... Class II ICU Medical, Inc.
Sep 28, 2012 Segmented Cervix Applicator Set, part number GM11004310, a component used wit... The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect fr... Class II Varian Medical Systems, Inc.
Sep 21, 2012 NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The N... Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component... Class II Zimmer, Inc.
Sep 20, 2012 The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non ... Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the... Class II Zimmer, Inc.
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.

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.