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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 1, 2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Head... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Feb 28, 2019 Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory inst... Lack of an adequate sterilization validation Class II Zimmer Biomet, Inc.
Dec 21, 2018 Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A... The product was potentially being packaged without a taper adapter. Class II Zimmer Biomet, Inc.
Nov 28, 2018 Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 P... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, Inc.
Nov 28, 2018 Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 ... There is a potential for silicone shedding during cleaning and sterilization. Class II Zimmer Biomet, 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 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.

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.