Dutch Ophthalmic USA recalls 23-gauge backflush brush needles labeled as 20-gauge. Mislabeled needles could cause surgical errors. Check product code 1281.B1D06 for affected items.
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
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Contact the company
📍Recalling firmDutch Ophthalmic USA, Inc.10 Continental Dr Bldg 1 · Exeter, NH 03833-7507
“Dutch Ophthalmic Disposable Backflush Brush Needles Mislabeled - 23 Gauge vs 20 Gauge.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63225-dutch-ophthalmic-disposable-backflush-brush-needles-mislabeled-23-gauge-vs. Based on FDA recall #Z-2091-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2021%22&limit=1).
The FDA announced on Feb. 25, 2021, that Dutch Ophthalmic USA, Inc. recalled Disposable Replacement Backflush Brush Needles due to mislabeling hazards. The agency said the product labels incorrectly stated a size of 20 gauge/0.9 mm instead of the correct 23 gauge/0.6 mm.
According to the FDA, the hazard is that the label states a size of 20 gauge/0.9 mm instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06.
Context
GovInfoNow's records show Dutch Ophthalmic USA, Inc. has two other recalls on record since May 21, 2019. Other recent recalls of similar products include DeRoyal Myocardial Probe Recall: Incorrect Needle Size Hazard (Aug. 20, 2026).
How to tell if you have this one
Check for product code 1281.B1D06 on the label. The lot number 3420011396 and UDI 08717872003757 are also associated with this mislabeled product.
Brand
Dutch Ophthalmic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Product Code
Check the product code on the label; affected items have code 1281.B1D06.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “Distribution in US states of IL, IN, MO, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2091-2021 (February 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2091-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.