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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Feb 13, 2019 BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device inten... The firm became aware of the potential for the products' sterile pouch to be punctured during tra... Class II Bioventus, LLC
Feb 8, 2019 Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... The integrity of the sterile grid packaging is potentially compromised. Class II Riverpoint Medical, LLC
Feb 7, 2019 Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui... Frayed pieces of the mounting card being inside the primary packaging. Class III Cordis Corporation
Jan 16, 2019 daVinci Harmonic ACE Curved Shears During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... Class II Intuitive Surgical, Inc.
Jan 9, 2019 Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Dec 26, 2018 Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... The sterile barrier may contain packaging seal defects. Class II Boston Scientific Corporation
Dec 26, 2018 Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma... The sterile barrier may contain packaging seal defects. Class II Boston Scientific Corporation
Dec 19, 2018 Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034... This recall has been initiated due to a change in packaging and sterilization method to address p... Class II XTANT MEDICAL INC
Dec 18, 2018 PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr... The sutures inside the packaging are not the same size or type as indicated on the label. Class II Ethicon, Inc.
Dec 5, 2018 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 The sterility may be compromised due to a potential breach in the packaging, even though it may a... Class III Medela 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 7, 2018 Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-... Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm ... Class II Hager & Meisinger Gmbh
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 Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... Class II COVIDIEN 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 26, 2018 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... packaging error; An internal QA inspection revealed that a incorrect healing collar could have ... Class II Implant Direct Sybron Manufacturing, LLC
Oct 22, 2018 PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flo... It is possible that the packaging of the product can be damaged by the prongs on the tube set. Class II WOM World of Medicine AG
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 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
Sep 24, 2018 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... Class II Johnson & Johnson Surgical Vision Inc
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Prod... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Pro... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... 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.