FDA Device recall Z-0844-2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124,…
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124,… by Coloplast Manufacturing Us, citing A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0844-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-02 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | US |
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
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Identifiers
| code_info | Device Reference Number AA6106, GTIN 3600040126851, Lot Numbers 7278611, 7326825, 7469914, 7528770, 7540052, 7616917,…Device Reference Number AA6106, GTIN 3600040126851, Lot Numbers 7278611, 7326825, 7469914, 7528770, 7540052, 7616917, 7680676, 7726724, 7748128, 7794789, 7874610, 7883406, 7948568, 7987184, 7987186, 7998885, 8097945, 8097947, 8097949, 8097950, 8149951, 8149954, 8156925, 8326511, 8326512, 8392428, 8452914, 8452915, 8519853, 8559628, 8572973, 8572977, 8728905, 8742746, 8796890, 8829455, 8899165, 8911320, 8996565, 9139298, 9177631, 9177632, 9192348, 9294521, 9294523, 9294524, 9315917, 9374195, 9404781, 9404782, 9419436, 9429227, 9429228, 9445801, 9453606, 9700652, 9711505, 9778601, 9778603, 9778606, 9792251, 9792257, 9817387, 9829471, 9843572, 9843573, 9940969 ; Device Reference Number AA6108, GTIN 3600040126981, Lot Numbers 7278611, 7326825, 7469914, 7528770, 7540052, 7616917, 7680676, 7726724, 7748128, 7794789, 7874610, 7883406, 7948568, 7987184, 7987186, 7998885, 8097945, 8097947, 8097949, 8097950, 8149951, 8149954, 8156925, 8326511, 8326512, 8392428, 8452914, 8452915, 8519853, 8559 |
|---|
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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FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
All Coloplast Manufacturing Us recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.