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

Recall Z-0106-2022 — Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

U.S. FDA — Device Enforcement · United States · 2021-08-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0106-2022
Date of alert
2021-08-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886874115978
Reported risk: Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
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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