ChannelCheck Convenience Pack — Class II medical device recall Z-1910-2025
Ongoing recall by Healthmark Industries Co., Inc., reported 2025-06-11, distributed nationwide. During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples t
| Recall number | Z-1910-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Healthmark Industries Co., Inc., Fraser, MI, United States |
| Recall initiated | 2025-05-02 |
| Classified | 2025-06-05 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MY |
| Quantity | 193,035 units |
| Lot numbers | 101673, 102096, 102807, 103293, 103312, 103564, 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 |
| Model numbers | UCC-222-ESP, UCC-222CP |
Product
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1910-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.