FDA Device recall Z-2091-2021
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, produ…
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, produ… by Dutch Ophthalmic Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-25 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dutch Ophthalmic Usa |
| Distribution | IL, IN, MO, PA |
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
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
Identifiers
| code_info | Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.