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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Feb 21, 2024 Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC
Feb 21, 2024 Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC
Oct 19, 2021 Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Numb... An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in er... Class II InfuTronix LLC
May 28, 2019 Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage:... Potential for tube leakage Class II InfuTronix 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.