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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 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 875 FDA device recalls.

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DateProductReasonClassFirm
Aug 6, 2019 ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331 The potential that the end of the shaft could fail to effectively mate with the broach with the C... Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jul 2, 2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812 Cleaning processes potentially being ineffective Class II Zimmer Biomet, Inc.
Jun 10, 2019 Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only)... Lack of an adequate sterilization validation. Class II Zimmer Biomet, Inc.
Jun 10, 2019 Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only)... Lack of an adequate sterilization validation. Class II Zimmer Biomet, Inc.
Jun 4, 2019 Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Ite... The products do not have sufficient data to support the labeled shelf life of 10 years. Class II Zimmer Biomet, Inc.
Jun 4, 2019 Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usa... The products do not have sufficient data to support the labeled shelf life of 10 years. Class II Zimmer Biomet, Inc.
May 28, 2019 K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Expre... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: The... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: Th... There is a potential for weak seals of the sterile packaging. 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 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.

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.