Product Wiki · Recalls · U.S. FDA — Device Enforcement

8MM,MEGA SUTURECUT ND,IS4000 REF 471309 — recall Z-0880-2025

U.S. FDA — Device Enforcement · United States · 2024-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0880-2025
Date of alert
2024-12-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886874119815
Reported risk: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.