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

Recall Z-2484-2025 — ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside t

U.S. FDA — Device Enforcement · United States · 2025-08-06 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2484-2025
Date of alert: 2025-08-06
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00821925043060

Reported risk: Potential for undetected, deformed a-traumatic tips.

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.

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.

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