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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
Dec 2, 2016 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Nov 28, 2016 Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Ca... Cook Medical has received reports of the trays containing the incorrect needle, which in some cas... Class II Cook Inc.
Nov 18, 2016 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... Labeled as a 48mm Cortical Screw but measuring at 50mm Class III OrthoPediatrics Corp
Nov 8, 2016 LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Inser... DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision Syste... Class II DePuy Orthopaedics, Inc.
Oct 31, 2016 MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba... Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and ca... Class II Roche Diagnostics Operations, Inc.
Oct 25, 2016 ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non... DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due... Class II Depuy Orthopaedics Inc.
Oct 11, 2016 ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori... Complaint of the head holder connector locking up mechanically when tightened. Class II Zimmer Biomet, Inc.
Oct 4, 2016 Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 0452812... Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quan... Class II Roche Diagnostics Operations, Inc.
Oct 4, 2016 COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Ca... .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-qua... Class II Roche Diagnostics Operations, Inc.
Sep 28, 2016 Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece Complaints have been reported that the handpiece is inoperable. The investigation found that the ... Class II Zimmer Biomet, Inc.
Sep 27, 2016 Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for cl... cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to... Class II Roche Diagnostics Operations, Inc.
Sep 15, 2016 Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Mod... Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire... Class II Battle Creek Equipment Co.
Sep 14, 2016 Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on ... Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect... Class II Roche Diabetes Care, Inc.
Aug 19, 2016 Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage:... Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ra... Class II Panoramic Rental Corp.
Aug 16, 2016 Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This pro... Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Mor... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve ... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling in... Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exi... Class II Hill-Rom, Inc.
Aug 9, 2016 Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and O... Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interch... Class II Zimmer Biomet, Inc.
Aug 9, 2016 Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and... Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal F... Class II Zimmer Biomet, Inc.
Aug 8, 2016 Vanguard 360 Revision Knee System Knee prostheses The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolt... Class II Zimmer Biomet, Inc.
Aug 2, 2016 Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smoot... The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and o... Class II Zimmer Biomet, Inc.
Jul 29, 2016 ROSA BRAIN 3.0.0 Non-conforming product label. Class II Zimmer Biomet, Inc.
Jul 27, 2016 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... Class II OrthoPediatrics Corp
Jul 27, 2016 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... Class II OrthoPediatrics Corp
Jul 20, 2016 ROSA Brain 3.0.0 Usage: The device is intended for the spatial positionin... Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller. Class II Zimmer Biomet, Inc.
Jul 15, 2016 Custom Made Tracheostomy Device The CADD Administration Sets with Flow Sto... Smiths Medical determined that a single custom Tracheostomy device had been shipped to the custom... Class II Smiths Medical ASD, Inc.
Jul 15, 2016 cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 312 Pre-Analytical System calculator/data processing module, for cli... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a comput... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clini... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage:... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800A Aliquoting System calculator/data processing module, for clinical u... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 612 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 512 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 501 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800 Sorting System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Affinity Four Birthing Bed Model P3700 The primary packaging is pictured... Class II Hill-Rom, Inc.
Jul 15, 2016 URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 VS II Aliquoter System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 701 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 471 centrifuge unit calculator/data processing module, for clinical ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Ch... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jun 24, 2016 Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-... Potential coating contamination with glass particles. Class I Cook Inc.
Jun 14, 2016 Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. ... The current construction of the side rail latch may not be able to support the full patient weigh... Class II Hill-Rom, Inc.
Jun 10, 2016 TSP Hip Fracture Plating System device, fixation, proximal femoral, implant ... The screw may fracture at the junction of the shaft and the head during implantation. The patient... Class II Biomet, Inc.
May 27, 2016 ROSA Brain 3.0 Intended for the spatial positioning and orientation of instr... Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. Class II Zimmer Biomet, Inc.
May 26, 2016 ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Van... Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin as... Class II Roche Diagnostics Operations, 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.