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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

Infrastructure

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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
Jul 29, 2015 NICO Myriad Console Model number NN-7000 The Myriad System is a surgical... Two cables within the console were inadvertently twisted during manufacturing. The individual wir... Class II Nico Corp.
Jul 28, 2015 Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. The device was assembled without screw hole plugs. Class II Biomet, Inc.
Jul 28, 2015 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part nu... The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a d... Class II OrthoPediatrics Corp
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 2, 2015 Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use i... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiog... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. ... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jun 24, 2015 S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood ... The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to ... Class II Roche Diagnostics Operations, Inc.
Jun 22, 2015 Contour Next Control Solution for Contour Next Blood Glucose Test System. Li... If the control solution bottle is not thoroughly shaken prior to use, the control test result may... Class II Bayer Healthcare, LLC
Jun 17, 2015 A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surg... Class II Biomet, Inc.
Jun 17, 2015 ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fat... Class II Zimmer, Inc.
Jun 12, 2015 ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: T... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surf... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation S... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articul... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Art... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 4, 2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. Class II Biomet, Inc.
Jun 4, 2015 A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedi... The thread location on one of the thread holes is offset from the axis of the predrill hole. The ... Class II Biomet, Inc.
Jun 4, 2015 Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take pan... Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. Class II Panoramic Rental Corp.
Jun 3, 2015 Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill gui... Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an i... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 10x25mm Round Head. An interference fixa... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 9x35mm Full Thread. An interference fix... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
May 28, 2015 Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 28, 2015 Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transju... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 18, 2015 M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (meta... Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinecti... Class I Zimmer, Inc.
May 14, 2015 LapSac Surgical Tissue Pouch. The current intended use for the LapSac Sur... Includes Information not stated in the intended use. Class II Cook Inc.
May 7, 2015 Triglycerides GPO. In vitro test for the quantitative determination of tri... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol tes... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) co... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholestero... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quant... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Triglycerides/Glycerol Blanked. In vitro test for the quantitative determi... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Uric Acid plus ver.2 In vitro test for the quantitative determination of u... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBA... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol gen.3. For the quantitative determination of high-density ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 1, 2015 Unilateral external fixation ankle clamp Product Usage: Unilateral extern... Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. Thi... Class II Biomet, Inc.
Apr 30, 2015 PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual ... Potential for uncured adhesive between the metal threaded insert and the impactor block to leak o... Class II Zimmer, Inc.
Apr 29, 2015 Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail... The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compat... Class II Zimmer, Inc.
Apr 22, 2015 Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. The Left and Right orientation of the trial was incorrectly etched on one side. When the instrum... Class II Biomet, Inc.
Apr 22, 2015 AccuChek Spirit insulin infusion pump. Roche has become aware of an increase of mechanical errors experienced by customers using the Acc... Class II Roche Diabetes Care, Inc.
Apr 22, 2015 AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo S... Roche has become aware of an increase of mechanical errors experienced by customers using the Acc... Class II Roche Diabetes Care, 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.