Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal Recalled by Dutch Ophthalmic USA, Inc. Due to Mislabeling

Date: February 25, 2021
Company: Dutch Ophthalmic USA, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dutch Ophthalmic USA, Inc. directly.

Affected Products

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

Quantity: 12 US

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 4 states: IL, IN, MO, PA

Affected (4 states)Not affected

About Dutch Ophthalmic USA, Inc.

Dutch Ophthalmic USA, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report