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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
Aug 15, 2019 XP-XP Tibial Tray - Interlok 91mm Item # 195761 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 83 mm Item # 195253 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 69mm Item # 195272 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 67mm Item # 195271 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 87 mm Item # 195760 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 87 mm Item # 195254 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP- CR Tibial Tray- Interlok 59mm Item # 195268 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 71 mm Item # 195755 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 71 mm Item # 195249 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 63 mm Item # 195751 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 79 mm Item # 195276 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 73mm Item # 195274 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 65mm Item # 195270 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 71mm Item # 195273 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 75 mm Item # 195757 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 69 mm Item # 195248 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 67 mm Item # 195753 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 63mm Item # 195269 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 65 mm Item # 195246 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 69 mm Item # 195754 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 83 mm Item # 195277 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 67 mm Item # 195247 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 79 mm Item # 195252 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 91 mm Item # 195279 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 73 mm Item # 195756 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 83 mm Item # 195759 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 73 mm Item # 195250 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 87 mm Item # 195278 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Interlok 75mm Item # 195275 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 63 mm Item # 195245 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 59 mm Item # 195750 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 Vanguard XP Tibial Tray 75 mm Item # 195251 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 65 mm Item # 195752 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
Aug 15, 2019 XP-XP Tibial Tray - Interlok 79 mm Item # 195758 The locking bar not fully engaging Class II Zimmer Biomet, Inc.
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.

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.