Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
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.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 21 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 Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The product... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 25 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 and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 22 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 and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case,... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,0... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,00... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 30 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 Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case,... 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 21 G X 1.5, 100 per box, 24 bo... 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 21 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 and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 box... 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 21 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 25 G X 1.5 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, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.

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.