FDA Medical Device Recalls (openFDA)
Healthmark Industries Co., Inc.: Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Recall number
- Z-1909-2025
- Recalling firm
- Healthmark Industries Co., Inc.
- Product
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Status
- Open, Classified
- Initiated
- 2025-05-02
- Posted
- 2025-06-05
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 250000 units
- Distribution
- US Nationwide and Internationally to countries of: Canada, Malaysia.
- Lot, serial or model codes
- Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 1000160387
- Firm city
- Fraser
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28