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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

1,040 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,040 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 1,040 FDA device recalls, Class III.

Clear
DateProductReasonClassFirm
May 27, 2015 PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 13, 2015 The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 261... The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the exp... Class III Bio-Rad Laboratories, Inc.
May 6, 2015 D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA ... Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. Class III Biocare Medical, LLC
May 6, 2015 VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique... The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab... Class III ORTHO-CLINICAL DIAGNOSTICS
Apr 28, 2015 RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U... Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's ... Class III Acclarent, Inc.
Apr 21, 2015 Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer... Devices were placed in a shipper carton without the appropriate number of the Instructions for Us... Class III Zimmer Surgical Inc
Apr 16, 2015 Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 16, 2015 MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... Class III Biomet, Inc.
Apr 9, 2015 Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... Some rods may not meet the appropriate traceability requirements including the lot number. Some ... Class III Spinal Elements, Inc
Mar 27, 2015 BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (G... BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophil... Class III Becton Dickinson & Co.
Mar 25, 2015 Universal Charger Product Usage: The Stryker Universal Battery Charg... The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... Class III Stryker Instruments Div. of Stryker Corporation
Mar 13, 2015 Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ... Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ... Class III Pointe Scientific, Inc.
Feb 27, 2015 Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. Class III Volk Optical Inc
Feb 27, 2015 Lombart 90D Clear with case Visualization during diagnosis and laser therapy... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... Class III Volk Optical Inc
Feb 25, 2015 Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... Class III Biomerieux Inc
Feb 25, 2015 Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... Class III Biomerieux Inc
Feb 25, 2015 Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... Class III Biomerieux Inc
Feb 24, 2015 LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... Mislabeled with an incorrect expiration date Class III LeMaitre Vascular, Inc.
Feb 19, 2015 Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... Class III Richard-Allan Scientific Company
Feb 19, 2015 ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... Class III Arc Medical Inc
Feb 11, 2015 Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t... Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST... Class III Milestone Scientific, Inc.
Feb 10, 2015 G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... Class III Tosoh Bioscience, Inc.
Jan 15, 2015 N Latex IgM; In-vitro diagnostic reagent for the quantitative determination o... Complaints have been confirmed on failed proficiency testing due to serum samples recovering too ... Class III Siemens Healthcare Diagnostics, Inc.
Jan 13, 2015 cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu... Class III Roche Molecular Systems, Inc.
Jan 9, 2015 Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... Class III Arrow International Inc
Jan 9, 2015 Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin... Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us... Class III Alivecor SFO
Dec 22, 2014 Flyte Togas are components of the Stryker Flyte System and are intended to be... A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... Class III Stryker Instruments Div. of Stryker Corporation
Dec 18, 2014 cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten... cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C... Class III Roche Molecular Systems, Inc.
Dec 17, 2014 Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep... The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L... Class III Smiths Medical ASD, Inc.
Dec 12, 2014 Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... Class III Pointe Scientific, Inc.
Nov 26, 2014 VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as Co... Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon conta... Class III Lacrimedics Inc
Nov 17, 2014 Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 11, 2014 Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... Class III Aesculap, Inc.
Nov 10, 2014 CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... The firm is informing customers of a software error that might result in an inaccurate display of... Class III Medtronic MiniMed Inc.
Nov 10, 2014 Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade... Incorrect lumi firmware version installed (E.027 instead of V2.00) Class III Tecan US, Inc.
Nov 10, 2014 Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w... Incorrect lumi firmware version installed (E.027 instead of V2.00) Class III Tecan US, Inc.
Nov 6, 2014 Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost... Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u... Class III Illumina Inc
Nov 4, 2014 LUNA Chest, Model No. LU4006 Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Class III Novadaq Technologies, Inc.
Nov 4, 2014 Non-sterile drape Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Class III Novadaq Technologies, Inc.
Oct 27, 2014 Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic... The product has been identified to contain an incorrect curette type. Class III CooperSurgical, Inc.
Oct 24, 2014 Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12... Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin lin... Class III AGFA Healthcare Corp.
Oct 23, 2014 MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC... MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values... Class III Medtest Holdings, Inc.
Oct 20, 2014 IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I... A typographical error regarding the expiration date was identified in the control module instruct... Class III Siemens Healthcare Diagnostics, Inc.
Oct 16, 2014 Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class III Biomerieux
Oct 16, 2014 Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te... The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class III Biomerieux

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.