Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling
Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The mislabeling of a surgical instrument's gauge is a risk-of-harm product without reported injuries, meeting the severity rubric criterion for score 3. Incorrect gauge identification in delicate vitreoretinal surgery could affect surgical outcomes.
Plain-English summary
Dutch Ophthalmic USA, Inc. is recalling Disposable Replacement Backflush Brush Needles (Product Number 1281.B1D06) due to incorrect labeling. The product label states the gauge is 20 gauge/0.9mm, but the actual needle is 23 gauge/0.6mm. Additionally, the packaging lists an incorrect product code.
These needles are used in vitreoretinal surgery, where precise instrument gauge is essential for proper surgical technique. The mislabeling creates a risk that surgeons may unknowingly use the wrong gauge needle, potentially affecting surgical accuracy.
The recall affects Lot Number 3420011396 (Unique Device Identifier 08717872003757) distributed in Illinois, Indiana, Missouri, and Pennsylvania. Affected healthcare facilities should identify and quarantine this inventory and verify packaging before use in surgical procedures.
The recalled product
- 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
- Manufacturer
- Dutch Ophthalmic USA, Inc.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
Distribution
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