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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Dec 4, 2018 BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LI... The internal labeling included with these implants may include incorrect part numbers and could r... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 3, 2018 iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121... The kits were prepared with incorrect patient ID labels and may contain incorrect components. Class II Conformis, Inc.
Dec 1, 2018 MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque St... The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feedin... Class II Canadian Hospital Specialties
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 21, 2018 Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits ... Potential that product has not reached complete sterilization, Class II American Contract Systems, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 20, 2018 Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... Class II Zimmer Biomet, Inc.
Nov 16, 2018 Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... Lead impedance values reported by the affected VNS generator will be higher compared to those rep... Class II LivaNova USA Inc
Nov 15, 2018 Revanesse Versa, PN40081 Labeling error. The product is labeled with an 18 month expiration date, however the product is a... Class II Prollenium Medical Technologies Inc.
Nov 13, 2018 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa... Class II Stryker Neurovascular
Nov 9, 2018 TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter ... A limited number of lenses may be mislabeled with the incorrect diopter power. Class II Tekia, Inc.
Nov 2, 2018 CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08,... The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... Class II CIVCO Medical Instruments Co., Inc.
Nov 2, 2018 CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket wit... Class II CIVCO Medical Instruments Co., Inc.
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... Class II Zimmer GmbH
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 30, 2018 Porcine Anorganic Bone Mineral 4.0cc There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an... Class III Collagen Matrix Inc
Oct 26, 2018 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX ... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Oct 26, 2018 Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, R... Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... Class II Merit Medical Systems, Inc.
Oct 24, 2018 NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoM... The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date... Class III Neomed Inc
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 22, 2018 Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 Label on the outer carton or the patient labels does not match label on the inner sterile packaging Class II Zimmer Biomet, Inc.
Oct 18, 2018 iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... Class II Beckman Coulter Inc.
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve S... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Ste... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 16, 2018 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 16, 2018 Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 16, 2018 Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 10, 2018 Comprehensive Mini Stem, Item No. 113631: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, Inc.
Oct 10, 2018 Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... Class II Zimmer Biomet, 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.