Food, drugs, devices › Coloplast Manufacturing US, LLC
Device recall: Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612
FDA enforcement event 95895 is a device recall by Coloplast Manufacturing US, LLC of Minneapolis, MN, initiated 2 Dec 2024 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Coloplast Manufacturing US, LLC has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Coloplast Manufacturing US, LLC, Minneapolis, MN.
Reason for recall
"A possible sterility issue was detected in Coloplast's facility on some Coloplast products."
Distribution
"US Nationwide. Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0844-2025 | 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. | 226,452 units | Class II | Ongoing | 22 Jan 2025 |
| Z-0845-2025 | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24. | 36,369 units | Class II | Ongoing | 22 Jan 2025 |
Context
Other enforcement events for Coloplast Manufacturing US, LLC
All 11 events for Coloplast Manufacturing US, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A possible sterility issue was detected in Coloplast's facility on some Coloplast products."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide. Canada."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.