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CATEGORY: SAFETY SURVEILLANCE
Medical Device Recall
An action taken by a manufacturer to correct or remove a marketed device that violates FDA regulations or may present a health risk. FDA classifies recalls as Class I (most serious), Class II, or Class III based on potential harm.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
A medical device recall (or field action) corrects or removes a distributed device that violates law or may pose risk. FDA classifies US recalls as Class I–III by health hazard.
PROCESS / STEPS
- Detect issue via complaints, manufacturing deviations, or regulator signals.
- Assess health hazard and decide correction/removal strategy.
- Notify regulators and customers; execute effectiveness checks.
- Document root cause and CAPA; close with status updates.
EXAMPLES
- Class I infusion pump software defect with serious injury risk.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Medical Device Recall across 27 authorities in real time.
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