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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
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 13, 2019 AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the ... AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an A... Class II Roche Diagnostics Operations, 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 23, 2019 Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Mod... Inaccurately Low Sample Results Class II Roche Diagnostics Operations, Inc.
Jul 23, 2019 Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Modu... Inaccurately Low Sample Results Class II Roche Diagnostics Operations, Inc.
Jul 18, 2019 Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 0... Quality issue with high pressure solenoid valves Class II Roche Diagnostics Operations, Inc.
Jul 18, 2019 cobas c513 Analyzer Quality issue with high pressure solenoid valves Class II Roche Diagnostics Operations, Inc.
Jul 18, 2019 cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 Quality issue with high pressure solenoid valves may cause inaccurate results. Class II Roche Diagnostics Operations, Inc.
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... Class II Roche Diagnostics Operations, Inc.
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... Class II Roche Diagnostics Operations, 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 The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay... The firm conducted internal investigations that confirmed customer complaints of quality control ... Class II Roche Diagnostics Operations, 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 7, 2019 Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... Class III Polymer Technology Systems, 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.