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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

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Apr 14, 2023 RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagn... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Apr 14, 2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 ... Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in ... Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2023 RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vit... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Apr 14, 2023 REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only N... Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Com... Class II Stryker Sustainability Solutions
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 12, 2023 Ultraview SL (UVSL) Command Module, Model 91496 Command modules will display the following when parameter processing is suspended, depending on s... Class II Spacelabs Healthcare, Inc.
Apr 12, 2023 Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Nu... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 12, 2023 Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... The product contains an expired diluent vial. If the impacted product is used, the sterility of t... Class II TELEFLEX LLC
Apr 12, 2023 Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: ... Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in m... Class II PHILIPS HEADQUARTERS CAMBRIDGE
Apr 11, 2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placem... Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Dril... Class II Integra LifeSciences Corp.
Apr 11, 2023 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... Class I Medtronic Navigation, Inc.
Apr 11, 2023 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... Class I Medtronic Navigation, Inc.
Apr 11, 2023 Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM;... Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter a... Class II Bard Peripheral Vascular Inc
Apr 10, 2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 In the remote occurrence in which the electrical contactor component present in the drying chambe... Class II Steris Corporation
Apr 10, 2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reli... Class II Keystone Industries
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Apr 10, 2023 Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Apr 7, 2023 Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring Sys... Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially lea... Class II Cytrellis Biosystems, Inc.
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Apr 6, 2023 3M Attest Steam Chemical Integrators, REF 1243A 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... Class II 3M Company - Health Care Business
Apr 6, 2023 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient ... There is a low possibility that an electrical connector in the MR gradient coil will overheat on ... Class II Elekta, Inc.
Apr 6, 2023 ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intende... Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.... Class II Hiossen Inc.
Apr 6, 2023 Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... Inadvertently released for distibution without sterility assurance. Class II Cardinal Health 200, LLC
Apr 6, 2023 Fisher Wallace Stimulator Models FW-100 and FW-200 If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, d... Class II Fisher Wallace Laboratories Inc.
Apr 6, 2023 Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... Metal sterilization trays used to encase and protect medical devices during sterilization have a ... Class II Karl Storz Endoscopy
Apr 6, 2023 3M Attest Steam Chemical Integrators, REF 1243B 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... Class II 3M Company - Health Care Business
Apr 5, 2023 Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... Class II Beckman Coulter Inc.
Apr 5, 2023 DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product ... DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... Class II Smiths Medical ASD Inc.
Apr 5, 2023 Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... Class II Draeger Medical Systems, Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... Class II CareFusion 303, Inc.
Apr 5, 2023 DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagn... Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... Class II Beckman Coulter, Inc.
Apr 5, 2023 Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls... The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... Class II Draeger Medical Systems, Inc.
Apr 5, 2023 ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product ... DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... Class II Smiths Medical ASD Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... Due to an automated dispensing cabinet software issue, when a medication single order contains mo... Class II CareFusion 303, Inc.
Apr 5, 2023 NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... Cybersecurity vulnerability concerning the software used for sequencing instruments. Class II Illumina, Inc.
Apr 5, 2023 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... Plastic sterilization trays used to encase and protect medical devices during sterilization have ... Class II Karl Storz Endoscopy
Apr 5, 2023 Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... Class II Beckman Coulter Inc.
Apr 5, 2023 Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calib... Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... Class II Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023 Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... Class II Beckman Coulter 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.