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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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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Apr 7, 2020 FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The... Potential for discrepant patient results due to a potential for the primary sample tube to be dil... Class II Inpeco S.A.
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Pro... In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... Class II Inpeco S.A.
Apr 7, 2020 FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00,... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FL... In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... Class II Inpeco S.A.
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Prismaflex Control Unit Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distr... Class II Baxter Healthcare Corporation
Apr 7, 2020 Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N F... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA ... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 6, 2020 SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type numbe... Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calcula... Class II Agfa N.V.
Apr 6, 2020 ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Us... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel det... It was determined that in rare cases persons can receive low dose of unintended radiation. The s... Class II Siemens Medical Solutions USA, Inc
Apr 6, 2020 OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 81384502005... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 81384502007... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - P... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model ... The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips... Class II Philips North America, LLC
Apr 6, 2020 OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat... It was determined that in rare cases persons can receive low dose of unintended radiation. The s... Class II Siemens Medical Solutions USA, Inc
Apr 6, 2020 CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Produ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 -... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usa... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 81384502000... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 8138450200... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UD... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Pr... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Pr... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, 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.