Recall Z-1909-2025 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Healthmark Industries Co., Inc.
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
| Date | Jun 5, 2025 (initiated May 2, 2025) |
| Status | Open, Classified |
| 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 o |
| Quantity | 250000 units |
| Distribution | US Nationwide and Internationally to countries of: Canada, Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.