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Healthmark Industries Co., Inc. recalls Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Recalled June 11, 2025 · FDA recall Z-1909-2025 · Healthmark Industries
Hazard
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. · FDA Class II
Units
250000 units
Sold at
US Nationwide and Internationally to countries of: Canada, Malaysia.
Description
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.
Product
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Manufacturer(s)
Healthmark Industries Co., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →