Folysil Silicone Foley Catheters — Class II medical device recall Z-0844-2025
Ongoing recall by Coloplast Manufacturing US, LLC, reported 2025-01-22, distributed nationwide. A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
| Recall number | Z-0844-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2024-12-02 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 226,452 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 03600040126851, 03600040126981, 03600040127117, 03600040127247, 03600040127377, 03600040127506, 03600040127612, 03600040127742, 03600040127872, 03600040128008, 03600040128268, 03600040128398, 03600040128527, 03600040128657, 03600040128787, 03600040128916, 03600040129043, 03600040129173, 03600040129302, 03600040129548, 03600040129654, 03600040129760, 03600040129876, 03600040129982, 03600040130094 and 7 more |
| Lot numbers | 7161409, 7161423, 7161607, 7174140, 7174152, 7174166, 7174170, 7174172, 7174266, 7187848, 7187849, 7187853, 7187855, 7187856, 7188119, 7193434, 7199153, 7199212, 7210663, 7210666, 7210671, 7210690, 7224527, 7229862, 7238889, 7238934, 7238937, 7255806, 7255852, 7255904, 7270676, 7270683, 7270685, 7270691, 7270693, 7270695, 7270715, 7278611, 7278618, 7278620 and 460 more |
Product
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
Reason for recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
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-0844-2025. 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.