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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

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

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DateProductReasonClassFirm
May 11, 2020 ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841... Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... Class II Radiometer Medical ApS
May 8, 2020 uCT 530 Computed Tomography X-Ray System Two issues were identified with the computed tomography x-ray system including a service function... Class II Shanghai United Imaging Healthcare Co., Ltd.
May 4, 2020 AC Powered hospital adjustable bed. Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall. Class II Umano Medical, Inc.
Apr 29, 2020 Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Cat... Product was not irradiated; therefore, they are not sterile and do not meet product specification. Class II Thermo Fisher Scientific (Monterrey)
Apr 24, 2020 ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ... Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High... Class II Abbott Gmbh & Co. KG
Apr 21, 2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus P... Signature from the user is necessary to proceed with specific actions in the Proton Therapy Syste... Class II Ion Beam Applications S.A.
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental u... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental ... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... A software issue that may affect the analyzer's result accuracy. Class II The Binding Site Group, Ltd.
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 7, 2020 Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-2... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 7, 2020 Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System used with the following Modules: High Vol... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 FlexLab Automation System used with the following Modules: High Volume Storag... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
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 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 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 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 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 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 3, 2020 VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 -... While transferring blood the needle may dislodged and remain in the tube stopper which may cause ... Class II C.A. Greiner & Sohne Gesellschaftmbh
Apr 3, 2020 Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... Class III Pega Medical Inc.
Mar 26, 2020 Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... In affected software version, of Positron emission tomography and computed tomography system, the... Class II Shanghai United Imaging Healthcare Co., Ltd.
Mar 23, 2020 Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 11165... The analyzer system may have an electrostatic discharge and sparking of the power supply provided... Class II Abbott Diagnostics Technologies AS
Mar 23, 2020 Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the tr... It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... Class II The Magstim Company Limited
Mar 23, 2020 Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated ... It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... Class II The Magstim Company Limited
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... Class II Rayner Intraocular Lenses Limited
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 10, 2020 ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... Class II Radiometer Medical ApS

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.