Pre-filled Water Syringe (Healthmark) – Contamination Risk (2025)
Improper use of water syringes can potentially lead to contamination during endoscope procedures.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Brand
Healthmark Industries Co., Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Healthmark Industries Co., Inc. is recalling Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 due to During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An "URGENT PRODUCT RECALL" notification letter was sent to customers beginning 5/2/25. Recommended Mitigations/ User Recommendations Please discontinue use of the Pre-Filled Water Syringes containing non-sterile water, which can be identified by a red cap. Any unused product can be returned for credit or replacement. Customer are requested to take the following actions 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected products have been transferred. 3. Contact Customer Service via email at HMCS@hmark.com or 800-521-6224 to return your unused affected product or if you have any questions. 4. Complete and return the response form Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026