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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

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.

Clear
DateProductReasonClassFirm
Apr 23, 2014 e.cam camera system. Emission Computed Tomography System used to detect or i... Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... Class II Siemens Medical Solutions USA, Inc.
Apr 18, 2014 Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d... Class II Leica Microsystems, Inc.
Apr 17, 2014 The Patient Control Module (PCM) is used in conjunction with a Baxter infusor... Potential for device malfunction resulting in flow when the device should not be flowing Class II Baxter Healthcare Corp.
Apr 17, 2014 Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an ele... Class II Nanosphere, Inc.
Apr 8, 2014 e.cam -emission computed tomography system Used to detect or image the dis... There is a potential for patient finger injury on the e.cam systems. Class II Siemens Medical Solutions USA, Inc.
Apr 3, 2014 AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... Class II Baxter Healthcare Corp.
Apr 3, 2014 The Centricity PACS Workstation is intended for use as a primary diagnostic a... It has been identified that in a reject image workflow where multiple studies are simultaneously ... Class II GE Healthcare
Mar 25, 2014 LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Consta... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 25, 2014 LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 25, 2014 LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); Fo... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 25, 2014 LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compat... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 25, 2014 LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Rese... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 20, 2014 Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... This lot did not go through the correct sterilization procedures. This product may potentially be... Class II Medline Industries Inc
Mar 18, 2014 Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ... Class III Nanosphere, Inc.
Mar 5, 2014 Symbia T and Symbia T2 computer tomography systems. These systems are used to... There are confirmed reports of a component coming loose inside the CT enclosure and damaging the ... Class II Siemens Medical Solutions USA, Inc.
Feb 26, 2014 Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... Class II Leica Microsystems, Inc.
Feb 25, 2014 LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inc... Hospira identified an incorrect lower lid (set component) had been supplied and was being used du... Class II Hospira Inc.
Feb 19, 2014 Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... The bar code that is printed on the Master Carton label does not correspond to the product code f... Class III Medefil Incorporated
Feb 18, 2014 GemStar Docking Station, used with GemStar infusion pump, in combination with... There are two situations that may occur when using the GemStar Docking Station, List Number 13075... Class I Hospira Inc.
Feb 12, 2014 ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (... Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... Class II Abbott Laboratories
Feb 12, 2014 ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibra... Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential... Class II Abbott Laboratories
Feb 7, 2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... Class I Baxter Healthcare Corp.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Feb 3, 2014 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one... Class I Hospira Inc.
Jan 31, 2014 GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (... The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump wi... Class II Hospira Inc.
Jan 24, 2014 LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 24, 2014 Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d... There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL ... Class II Hospira Inc.
Jan 10, 2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... Product does not function as intended up to the expiry date on the product labeling. There is a ... Class II Leica Microsystems, Inc.
Nov 23, 2013 The Abbott m2000sp is an automated system for performing sample preparation f... The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling a... Class II Abbott Molecular
Nov 8, 2013 IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin... Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ... Class II Baxter Healthcare Corp.
Nov 4, 2013 Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... Class II Medline Industries Inc
Oct 31, 2013 Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly... Class I Hospira Inc.
Oct 31, 2013 Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Enc... Class I Hospira Inc.
Oct 28, 2013 Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient c... Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Class II Siemens Medical Solutions USA, Inc.
Oct 28, 2013 e.cam line of gamma camera systems Used to detect or image the distributi... Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Class II Siemens Medical Solutions USA, Inc.
Oct 25, 2013 *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ... Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assemb... Class II Hospira Inc.
Oct 17, 2013 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubin... The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully c... Class II Baxter Healthcare Corp
Oct 16, 2013 The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho... The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that... Class II Baxter Healthcare Corp.
Oct 16, 2013 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte... Class III Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene S... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
Sep 25, 2013 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... Incomplete foil seal on one lot of sterile product. Class II Baxter Healthcare Corp.
Sep 24, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Sep 20, 2013 The Vantage Digital Panoramic System delivers high-value features standard on... An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.... Class II Midmark Corp dba Progeny Inc
Sep 18, 2013 Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; V... Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporizat... Class II Richard Wolf Medical Instruments 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.