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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jul 22, 2025 RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100... Due to incorrect software configuration that potentially allows more than two (2) fractions withi... Class II Reflexion Medical, Inc.
Apr 16, 2024 RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Rad... A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. Class II Reflexion Medical, Inc.
Nov 24, 2021 RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF ... Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orie... Class II Reflexion Medical, 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.