CLASS II Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
Disposable Replacement Backflush Brush Needles (/-for use recalled
Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (/-for use in vitreoretinal surgery, distributed in Illinois, Indiana, Missouri, Pennsylvania. The recall was initiated on 25 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2091-2021
- FDA event ID
- 88153
- Recalling firm
- Dutch Ophthalmic USA, Exeter, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2021
- FDA classified
- 19 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 25 Feb 2021 | Recall initiated by company | |
| 19 Jul 2021 | Classified by FDA | +144 days |
| 28 Jul 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Where it was distributed
Distribution in US states of IL, IN, MO, PA.
Questions about this recall
Is Disposable Replacement Backflush Brush Needles (/-for use in vitreoretinal surgery recalled?
Yes. Dutch Ophthalmic USA recalled Disposable Replacement Backflush Brush Needles (/-for use in vitreoretinal surgery on 25 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-2091-2021.
Why was it 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
Which lots are affected?
Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
Where was it sold?
Distribution in US states of IL, IN, MO, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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