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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

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodge... Class II Bard Peripheral Vascular Inc
Mar 25, 2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coron... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Mar 25, 2021 ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. Fo... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal proce... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spina... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catal... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Mar 25, 2021 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 24, 2021 BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qu... BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed ... Class II Becton Dickinson & Co.
Mar 24, 2021 Drop Arm Versamode" The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. Class II Gf Health Products
Mar 24, 2021 Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by ... Aftermarket front bezel components were installed during service/repair, not by the original manu... Class I Pacific Medical Group Inc.
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 VenaSeal Closure System Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... Class III Medtronic Inc.
Mar 23, 2021 Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for moni... Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of h... Class II Philips North America, LLC
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA Product may be contaminated with Burkholderia contaminans. Class II Sunstar Americas, Inc.
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Mar 22, 2021 Spectrum Medical Quantum Standard heat exchanger Product labeled as sterile may not have been adequately sterilized. In addition, these devices we... Class II QURA S.R.L.
Mar 22, 2021 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 22, 2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KV... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 22, 2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 1... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE DRILL, CODE INTVM-DRL Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 Normand Remisol Advance Data Manager is a software device that interfaces bet... Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions reg... Class II Normand-Info S.A.S.U.
Mar 22, 2021 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, RE... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 22, 2021 BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement m... Products labeled as sterile were distributed, but may not have been sterilized. Class II BIOPSYBELL S.R.L.
Mar 19, 2021 Centricity Universal Viewer - Product Usage: intended to assist in the viewi... When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workfl... Class II GE Healthcare, LLC
Mar 19, 2021 Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the cont... Potentially defective component in the AC power adapter which may fail over time. Class II Baxter Healthcare Corporation
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL482... Malfunction- loosening of the implant resulting in a potential revision surgery Class II Aesculap Implant Systems LLC

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.