Drug recall
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116…
FDA recall event 95895 · Class II · Coloplast Manufacturing US, LLC
Key facts
| Event ID | 95895 |
|---|---|
| Recall numbers | Z-0844-2025, Z-0845-2025 |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Product type | Devices |
| Products | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| Initiation date | Dec 2, 2024 |
| Report date | Jan 22, 2025 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2125050 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: