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类别: SAFETY SURVEILLANCE
医疗器械召回
制造商为纠正或移除违反FDA法规或可能存在健康风险的已上市器械而采取的行动。FDA将召回分为I类（最严重）、II类和III类。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 医疗器械召回 across 27 authorities in real time.
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