Healthmark Industries Co., Inc.: Medical Device Recall in 2025 - (Recall #: Z-1909-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 2, 2025

Date Posted: June 11, 2025

Recall Number: Z-1909-2025

Event ID: 96823

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 250000 units

Code Information:

Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013

Distribution Pattern:

US Nationwide and Internationally to countries of: Canada, Malaysia.

Voluntary or Mandated:

Voluntary: Firm initiated