FDA Device recall Z-1909-2025
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 by Healthmark Industries, citing 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 inv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1909-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-02 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Healthmark Industries |
| Distribution | US |
Product
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
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.
Identifiers
| code_info | Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1909-2025%22
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