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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
May 10, 2013 Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr )... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOL... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,..... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(15... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/si... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2m... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
May 10, 2013 Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC
Feb 25, 2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... Class I Symbios Medical Products, 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.