Dutch Ophthalmic USA, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2252-2021)

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:

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Product Classification:

Class II

Date Initiated: May 21, 2019

Date Posted: August 18, 2021

Recall Number: Z-2252-2021

Event ID: 88162

Reason for Recall:

Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

Status: Ongoing

Product Quantity: 16 boxes

Code Information:

Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294

Distribution Pattern:

US Nationwide Distribution in the states of AL, CA, CO, FL, MI

Voluntary or Mandated:

Voluntary: Firm initiated