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

Recall Z-2091-2021 — Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

U.S. FDA — Device Enforcement · United States · 2021-02-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2091-2021
Date of alert
2021-02-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Dutch Ophthalmic USA, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3420011396
Reported risk: Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
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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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.