Z-2091-2021Class II

Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product...

Name: Z-2091-2021 Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product...
Creator: Dutch Ophthalmic USA, Inc.
Published: 2021-02-25
License: https://open.fda.gov/license/

Dutch Ophthalmic USA, Inc. / initiated 2021-02-25 / Terminated / root cause: labeling and UDI

FDA source

Dutch Ophthalmic USA, Inc. began a recall of Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06 on 2021-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2091-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-25
Posted: 2021-07-19
Terminated: 2021-11-05
Recalling firm: Dutch Ophthalmic USA, Inc.
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
Product code: HMX Cannula, Ophthalmic
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Dutch Opthalmic issued Urgent Medical Device Recall letter on 2/25/21 stating reason for recall, health risk and action to take: We request that you take the following immediate actions: Verify whether you have unused boxes or individual blisters of LOT 3420011396 in your inventory and quarantine product subject to this reca ll. Contact Customer Service at our distributor Dutch Ophthalmic, USA at 1-800-753-8824 x 1 to receive a Return Material Authorization (RMA) number and receive instructions on how to return the unused affected product. Complete the attached Device Recall Reconciliation Form, sign it and return a scan or photo of the signed form by email to [email protected]. Add the original completed and signed Device Recall Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next few days a Service rep will contact you to discuss replacement of returned products. Contact Dutch Ophthalmic 1-800-753-8824 x1 for assistance.
Quantity in commerce: 12 US
Distribution: Distribution in US states of IL, IN, MO, PA.
Product codes and lots: Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)