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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
Jun 7, 2019 PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... 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.
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.
Jun 3, 2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... Class II Roche Diagnostics Corporation
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.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Ca... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 3, 2019 Accu-Chek Connect Diabetes Management App Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to t... Class II Roche Diabetes Care, Inc.
May 2, 2019 Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT The products may have been manufactured without the bottom seal on the outer packaging, compromis... Class II Cook Inc.
Apr 26, 2019 Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-10... may contain a damaged gray safety lock knob, which could potentially result in difficulty or an i... Class II Cook Inc.
Apr 22, 2019 Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: ... Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... Class II Cook Inc.
Apr 22, 2019 Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.... Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... Class II Cook 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 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Thoracentesis Set, RPN C-THS-850, Order # G03286 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 4, 2019 cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 4, 2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
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.

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.