Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The device is a 25-gauge infusion line that is part Recalled by Dutch Ophthalmic USA, Inc. Due to Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC...

Date: May 21, 2019
Company: Dutch Ophthalmic USA, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dutch Ophthalmic USA, Inc. directly.

Affected Products

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.

Quantity: 16 boxes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Dutch Ophthalmic USA, Inc.

Dutch Ophthalmic USA, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report