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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Apr 21, 2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 20, 2021 Logical cup liner - Product Usage: intended to replace a hip joint where bone... Product mislabeled, with the incorrect product inside the package. Class II Signature Orthopedics Pty Limited
Apr 14, 2021 Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrec... Barcode label extended expiration date. Barcode located at the short side of the outer box shows ... Class II Dutch Ophthalmic USA, Inc.
Apr 9, 2021 PERLA TL Lateral Connector Open - Product Usage: intended to be used with aut... Due to external labelling error/mix-up. Affected product external labels list the incorrect rod ... Class II SPINEART SA
Apr 8, 2021 Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR ... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 8, 2021 CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class II Smith & Nephew, Inc.
Apr 8, 2021 Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bo... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 5, 2021 GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliar... The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endopros... Class II W.L. Gore & Associates, Inc.
Apr 1, 2021 Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF:... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Apr 1, 2021 Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used ... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Apr 1, 2021 Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Pro... single use devices labeled as sterile may not have been adequately sterilized Class II CLINICAL LASERTHERMIA SYSTEMS AB
Mar 31, 2021 Palm Cups - Product Usage: intended to be used to percuss the chest wall to m... The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... Class II Smiths Medical ASD Inc.
Mar 31, 2021 ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the d... The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... Class II Smiths Medical ASD Inc.
Mar 31, 2021 AM12M Acquisition Module accessory. Impacted software version of the AM12M i... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 26, 2021 INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibia... Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide syst... Class II ConMed Corporation
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.

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.