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

Recall Z-1906-2020 — da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

U.S. FDA — Device Enforcement · United States · 2018-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1906-2020
Date of alert
2018-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886874113486
Reported risk: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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