Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 14, 2018 Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT... Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. Class II Zimmer Biomet, Inc.
Oct 31, 2018 NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size ... Screw is missing from the package Class II Zimmer Biomet, Inc.
Oct 24, 2018 Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inser... Potential metal burrs in the holes of the device preventing the appropriate drill and transverse... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Di... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Num... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diam... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Le... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, 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 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... 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 22, 2018 Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item N... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm ... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 12, 2018 Zimmer Compress Devices and Instruments: Item Number/Item Description 17835... Correction to update the surgical technique for the Compress System. To make users aware of the c... Class II Zimmer Biomet, 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.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 Th... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Oct 2, 2018 Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Aff... The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Sep 21, 2018 StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-us... There is a potential for comingling of the 43MM and 51 MM molds Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Numbe... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pac... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref N... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 22, 2018 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pa... Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. Class II Zimmer Biomet, Inc.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 ... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
Aug 9, 2018 HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 H... HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in th... Class II Biomet UK Ltd.
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.

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.