Healthmark recalls Pre-filled Water Syringes (SW-010-100, SW-010) due to improper use outside intended purpose during endoscope surveillance. Affected units include specific lot numbers.
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.
Healthmark is recalling Pre-filled Water Syringes with model numbers SW-010-100 and SW-010 because they were improperly used outside their intended purpose during endoscope surveillance. This could lead to contamination risks if the syringes are used incorrectly.
The syringes were found contaminated during endoscope surveillance monitoring. Healthmark determined the contamination occurred because the syringes were used improperly outside their intended medical purpose.
Healthmark Pre-filled Water Syringes with model numbers SW-010-100 and SW-010 are likely used by medical professionals for endoscope procedures. Those using the syringes outside their intended purpose are at higher risk.
Check for model numbers SW-010-100 or SW-010 on the syringe. Affected units include lot numbers 200001 through 200013.
Identify the model number on the syringe to see if it matches SW-010-100 or SW-010.
Confirm the lot number is between 200001 and 200013 to determine if the syringe is affected.
Healthmark determined the syringes were contaminated during endoscope surveillance because they were used improperly outside their intended purpose.
Model numbers SW-010-100 and SW-010 are affected.
Lot numbers 200001 through 200013 are affected.
We’ve drafted a message you can send Healthmark to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2025 — Healthmark Healthmark Hello, I own a Healthmark that is covered by recall Z-1909-2025 from Healthmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
