Intuitive Surgical, Inc. recalls 8MM,FORCE BIPOLAR,IS4000 REF 471405
- Recall date
- December 19, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0883-2025
- FDA classification
- Class II
- Brand / firm
- Intuitive Surgical, Inc.
- Sold / distributed
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebr…
Why it was recalled
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
8MM,FORCE BIPOLAR,IS4000 REF 471405
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