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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 20, 2016 Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOS... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in ... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in ... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOS... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITR... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the qu... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in th... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, Inc.
Jul 20, 2016 Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC U... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a ... Class III Sterling Diagnostics, 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.