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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Mar 26, 2021 The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont... An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal... Class II Boston Scientific Corporation
Mar 26, 2021 VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black R... Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly l... Class II Ortho-Clinical Diagnostics, INc.
Mar 26, 2021 KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibi... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
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 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 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 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 17, 2021 Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1... Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Ma... Class II SIGHT DIAGNOSTICS LTD
Mar 17, 2021 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Cathe... Incorrect labeling, Catheter did not have the required holes and markings Class II Integra LifeSciences Corp.
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Mar 5, 2021 MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 5, 2021 MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 2, 2021 Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - Fa... Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24... Class II AZURE BIOTECH INC
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... Class II Heartware, Inc.
Feb 25, 2021 Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vi... Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 m... Class II Dutch Ophthalmic USA, Inc.
Feb 24, 2021 KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. Class III Microbiologics Inc
Feb 24, 2021 KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. Class III Microbiologics Inc
Feb 22, 2021 RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... Class II RAYSEARCH LABORATORIES AB
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 16, 2021 EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - ... Contact lenses may be mislabeled with the incorrect lens power. Class II Clerio Vision
Feb 11, 2021 JUDKINS PACK Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... Class II Cardinal Health 200, LLC
Feb 5, 2021 Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... Class III OraSure Technologies, Inc.
Feb 4, 2021 Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz... The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) int... Class II Siemens Medical Solutions USA, Inc.
Jan 28, 2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class III OriGen Biomedical, Inc.
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 21, 2021 Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/S... The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), in... Class II CooperSurgical, Inc.
Jan 21, 2021 Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... Class II G & H Wire Company
Jan 19, 2021 HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consis... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, 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.