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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Leng... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, ... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-225... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 26, 2018 M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter... Potential failure of sterile packaging seal. Class II Zimmer Biomet, Inc.
Mar 22, 2018 Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intende... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 22, 2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intend... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 14, 2018 PTS Panels¿ CHOL+GLU Test Strips (REF 1765) Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated s... Class II Polymer Technology Systems, Inc.
Mar 12, 2018 Phoenix Nail System, intended for use with an intramedullary nail system for ... Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to repor... Class II Zimmer Biomet, Inc.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, Inc.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, Inc.
Feb 28, 2018 Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic impla... During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of re... Class II Biomet, Inc.
Feb 22, 2018 Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 19, 2018 SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-M... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Feb 19, 2018 EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 8005082... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Feb 6, 2018 AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810... The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acc... Class II Zimmer Biomet, Inc.
Jan 31, 2018 StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)0082... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)008270025... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)108... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UD... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 24, 2018 Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 3... One lot of humeral stem implants do not include the humeral bushing components. Class II Zimmer Biomet, Inc.
Jan 12, 2018 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is ... The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... Class II Cook Inc.
Jan 12, 2018 Progressa Bed - AC-powered adjustable hospital bed A component used within the braking system may break resulting in one or more brake pedals on the... Class II Hill-Rom, Inc.
Jan 12, 2018 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a m... The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... Class II Cook Inc.
Jan 3, 2018 Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UD... Two lots of hip implants are mislabeled. Class II Zimmer Biomet, Inc.
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... Class II Roche Diagnostics Corporation
Dec 22, 2017 Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination... Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to th... Class II Roche Diagnostics Corporation
Dec 21, 2017 (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100,... The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system ... Class II DePuy Orthopaedics, Inc.
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 13... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 D... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAI... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... 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.