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

Recall Z-1055-2021 — NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

U.S. FDA — Device Enforcement · Japan · 2021-01-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1055-2021
Date of alert: 2021-01-04
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Aomori Olympus Co., Ltd.
Product category: device
Product type: Devices

Reported risk: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

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.

Recall Z-1055-2021 — NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

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