Class II — Potential Health Hazard

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

Pre-filled Water Syringe Recalled by Healthmark Industries Co., Inc. Due to During endoscope surveillance monitoring, a user facility identified...

Date: May 2, 2025
Company: Healthmark Industries Co., 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 Healthmark Industries Co., Inc. directly.

Affected Products

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

Quantity: 250000 units

Why Was This Recalled?

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Healthmark Industries Co., Inc.

Healthmark Industries Co., Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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