# FDA recall Z-2091-2021

> **Dutch Ophthalmic USA, Inc.** · Class II · device recall initiated 2021-02-25.

## Product

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

## Reason for recall

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

## Distribution

Distribution in US states of IL, IN, MO, PA.

## Key facts

- **Recall number:** Z-2091-2021
- **Recalling firm:** Dutch Ophthalmic USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-25
- **Report date:** 2021-07-28
- **Termination date:** 2021-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Exeter, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2021

## Citation

> AI Analytics. FDA recall Z-2091-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2091-2021. Source: US FDA. Licensed CC0.

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