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

Recall Z-1615-2023 — ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

U.S. FDA — Device Enforcement · United States · 2023-03-31 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1615-2023
Date of alert
2023-03-31
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170388248
Reported risk: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
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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