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
Dutch Ophthalmic USA recalls disposable backflush brush needles that are mislabeled as 20-gauge/0.9mm instead of the correct 23-gauge/0.6mm size. This could lead to surgical errors if used in vitreoretinal procedures. Affected items have product code 1281.B1D06 and lot number 3420011396.
The needles are mislabeled as 20-gauge/0.9mm when they should be 23-gauge/0.6mm. This size difference could cause improper surgical procedures if used in vitreoretinal surgery. The risk is limited to surgical teams using the needles without verifying the correct size.
Surgical teams using these needles for vitreoretinal surgery are most at risk. Patients and medical staff who own the mislabeled needles may need to verify the correct product.
Check for product code 1281.B1D06 on the label. The lot number 3420011396 and UDI 08717872003757 are also associated with this mislabeled product.
Check the product code on the label; affected items have code 1281.B1D06.
The needles are mislabeled as 20-gauge/0.9mm instead of the correct 23-gauge/0.6mm size, which could lead to surgical errors.
Look for product code 1281.B1D06 on the label, lot number 3420011396, or UDI 08717872003757.
No action is required if you have the correct product. Only verify the product code to ensure you have the correct size.
We’ve drafted a message you can send Dutch Ophthalmic to request your refund or repair — edit it as you like.
Subject: Recall Z-2091-2021 — Dutch Ophthalmic Dutch Ophthalmic Hello, I own a Dutch Ophthalmic that is covered by recall Z-2091-2021 from Dutch Ophthalmic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
