Dutch Ophthalmic USA, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2091-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 25, 2021

Date Posted: July 28, 2021

Recall Number: Z-2091-2021

Event ID: 88153

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

Status: Terminated

Product Quantity: 12 US

Code Information:

Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757

Distribution Pattern:

Distribution in US states of IL, IN, MO, PA.

Voluntary or Mandated:

Voluntary: Firm initiated