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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

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Jul 13, 2012 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 6, 2012 Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic ... Baxter discovered that a Baxter technical service representative was providing incorrect instruct... Class II Baxter Healthcare Renal Div
Jul 3, 2012 Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral so... The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR... Class II Chicago X-Ray Systems, Inc.
Jun 29, 2012 Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Prod... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 29, 2012 Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street... ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an... Class II Arjo, Inc. dba ArjoHuntleigh
Jun 15, 2012 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri... Class II Ge Healthcare It
Jun 4, 2012 Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reducti... Class II Leica Microsystems, Inc.
Jun 1, 2012 Sysmex XE-2100 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-5000 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-2100C Automated Hematology System; an automated differential cell c... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
May 30, 2012 ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (... The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Ab... Class II Abbott Laboratories
May 29, 2012 AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
May 29, 2012 AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
May 29, 2012 AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ... The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... Class I Carefusion 2200 Inc
Apr 19, 2012 The GE Centricity Web; Software Version 3.0x, is intended for use under the d... GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... Class II Ge Healthcare It
Apr 11, 2012 Symbia E is a multi-purpose SPECT system used to detect or image the distribu... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class II Siemens Medical Solutions USA, Inc.
Apr 11, 2012 E.CAM emission computed tomography system used to detect or image the distrib... Radial motor drives replaced during a customer service action were incorrectly assembled backwards. Class II Siemens Medical Solutions USA, Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: Th... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Jan 31, 2012 Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up t... In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modify... Class II Abbott Molecular
Mar 16, 2011 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira Inc.
Mar 16, 2011 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira Inc.
Mar 4, 2011 Imagecast PACS is an image management system intended to be used by trained p... In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was... Class II Ge Healthcare It
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
May 20, 2010 HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, ... CGMP Deviations: Incomplete documentation associated with test results. Class II App Pharmaceuticals Llc
May 20, 2010 HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, ... CGMP Deviations: Incomplete documentation associated with test results. Class II App Pharmaceuticals Llc
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.

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.