Disposable Replacement Backflush Brush Needles — Class II medical device recall Z-2091-2021
Terminated recall by Dutch Ophthalmic USA, Inc., reported 2021-07-28, distributed in IL, IN, MO, PA. Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of
| Recall number | Z-2091-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dutch Ophthalmic USA, Inc., Exeter, NH, United States |
| Recall initiated | 2021-02-25 |
| Classified | 2021-07-19 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2021-11-05 |
| Distributed | IL, IN, MO, PA |
| Quantity | 12 us |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08717872003757 |
| Lot numbers | 3420011396 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2091-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.