Medical device recalls Moderate risk

Intuitive Surgical, Inc. recalls 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

Recall date
December 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0878-2025
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,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

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