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Browse Device Recalls

111 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 111 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 111 FDA device recalls.

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DateProductReasonClassFirm
Aug 28, 2012 Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers a... Embedded iron oxide glass defect which may have the potential to break off into the solution. Class II Hospira Inc.
Jul 13, 2012 Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch wi... The float valve in the burette sticks to the burette wall and does not open or close properly. Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: Th... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Feb 5, 2012 *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... Class II Hospira Inc.
Mar 16, 2011 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira Inc.
Mar 16, 2011 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira 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.