Disposable Replacement Backflush Brush Needles (23… recallZ-2091-2021 · Dutch Ophthalmic USA, Inc. · initiated Feb 25, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dutch Ophthalmic USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Under Investigation by firm
What the company is doing
Dutch Opthalmic issued Urgent Medical Device Recall letter on 2/25/21 stating reason for recall, health risk and action to take: We request that you take the following immediate actions: Verify whether you have unused boxes or individual blisters of LOT 3420011396 in your inventory and quarantine product subject to this reca ll. Contact Customer Service at our distributor Dutch Ophthalmic, USA at 1-800-753-8824 x 1 to receive a Return Material Authorization (RMA) number and receive instructions on how to return the unused affected product. Complete the attached Device Recall Reconciliation Form, sign it and return a scan or photo of the signed form by email to [email protected]. Add the original completed and signed Device Recall Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next few days a Service rep will contact you to discuss replacement of returned products. Contact Dutch Ophthalmic 1-800-753-8824 x1 for assistance.
Recall details
- Recall number
- Z-2091-2021
- Status
- Terminated
- Initiated by the company
- Feb 25, 2021
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Quantity
- 12 US
- Product code
- HMX
- Distribution
- Distribution in US states of IL, IN, MO, PA.
Product description
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Code information (models, lots, serial numbers)
Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Disposable Replacement backflush brush Needles. (23 gauge / 0.6mm) 1281.B1D06D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Cannula, Ophthalmic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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