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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 23, 2017 | Piston Syringe, 60 CC L/S, 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, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The produ... | 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 23 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, 20 CC L/L, 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 | Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 b... | 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 21 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 | Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 b... | 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 1.0, 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 22 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 | Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The produ... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 27 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 | Hypodermic Needle, 22 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 and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 b... | 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 25 G X 5/8, 100 per box, 24 bo... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Hypodermic Needle, 16G X 1.5in 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, 20 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 25 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, 21 G X 1.5 in YALE DISP, 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, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The prod... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The produ... | 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 1.25, 100 per box, 24 b... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe and Hypodermic Needle, 1 CC TB 27 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, 5 CC L/L 22 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 | Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluid... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 23, 2017 | Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The prod... | Insufficient documentation to support product sterility claims. | Class II | International Medsurg Connection, Inc. |
| Jun 21, 2017 | PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation S... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixa... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMI... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
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.