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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tr... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Nov 7, 2025 Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr... IFU and device kit labeling contains misleading statements leading to improper securing of the de... Class II Rocket Medical Plc
Aug 1, 2019 Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 A complaint was received regarding kinking of the device prior to use. If a device is kinked it c... Class II Rocket Medical Plc

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.