FDA Device recall Z-1910-2025
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) 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-1910-2025 |
| 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
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
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: 200014 200015 200016 900153 900154 900155 900156 900157 900158 900159 900160 900161 900162 900163 900164 9…Lot Numbers: 200014 200015 200016 900153 900154 900155 900156 900157 900158 900159 900160 900161 900162 900163 900164 900165 900166 900167 900168 900169 900170 900171 900172 900173 900174 900175 900176 900177 103564 103312 103293 102807 102096 101673 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1910-2025%22
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