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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
Sep 18, 2017 Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Inte... The torque wrench used to tighten system bolts during installation was found to be out of tolerance Class II Siemens Medical Solutions USA, Inc.
Sep 8, 2017 Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a dil... There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) res... Class II Sysmex America, Inc.
Sep 5, 2017 Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class II Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Patient Positioning System with KRC2 controller using software versions 2.3.1... Communications between the Patient Positioning System and the accuracy filter can periodically fa... Class II Forte Automation Systems Inc
Sep 5, 2017 Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Medline Prefilled 550 ml Sterile¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex Unit Dose 15 ml Normal Saline ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Aug 10, 2017 Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... Class II Medline Industries Inc
Aug 10, 2017 Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... Class II Medline Industries Inc
Aug 1, 2017 Presource(R) Kits (custom surgical/procedural kits): The standard and custom... The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... Class II Cardinal Health 200, LLC
Jul 28, 2017 Convertors Robotic Drape with Attached Leggings; Product is packaged as Singl... Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. Class II Cardinal Health 200, LLC
Jul 27, 2017 Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... A leak may allow for microbial contamination of the sterile fluid path. Class II Baxter Healthcare Corporation
Jul 18, 2017 AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ... Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect... Class II Vyaire Medical
Jul 18, 2017 Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek pla... Product did not undergo correct sterilization procedures and may potentially be non-sterile. Class II Medline Industries Inc
Jul 14, 2017 Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, R... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intende... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is int... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody i... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is in... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 14, 2017 Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is inte... A delay in transit may have contributed to nonconformity as the product was stored outside of def... Class II Leica Biosystems Richmond Inc.
Jul 10, 2017 Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to ... Two specific lots was incorrectly manufactured containing a UK power adapter. Class III AMEDA, INC.
Jul 5, 2017 HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jul 5, 2017 HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jun 27, 2017 Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 27, 2017 Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 23, 2017 Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The product... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, 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.