FDA Device recall Z-0845-2025
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6…
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6… 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-0845-2025 |
| 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
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.
Reason
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Identifiers
| code_info | Device Reference Number AB6022, GTIN 3600040143377, Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823,…Device Reference Number AB6022, GTIN 3600040143377, Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 ; Device Reference Number AB6024, GTIN 3600040143506, Lot Numbers: 8156931, 8865281, 9102857, 9453594 ; Device Reference Number AB6118, GTIN 3600040143636, Lot Numbers: 8691180; Device Reference Number AB6120, GTIN 3600040143728, Lot Numbers: 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 ; Device Reference Number AB6122, GTIN 3600040143810, Lot Numbers: 7562886, 7562887; Device Reference Number AB6124, GTIN 3600040143902, Lot Numbers: 7396107, 9102869, 9429206 ; Device Reference Number AB6220, GTIN 3600040144046, Lot Numbers: 8460192, 8529285; Device Reference Number AB6222, GTIN 3600040144091, Lot Numbers: 8442243, 8459924, 8529346, 8592925, 8806400; Device Reference Number AB6224, GTIN 3600040144145, Lot Numbers: 8442214, 8559578, 9112300 ; Device Reference Number AB6318, GTIN 3600040144190, Lot Numbers: 7637490, 7670546, 8484834, 8498250, 8529294, 852 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Coloplast Manufacturing Us
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FDA Device · Class II · 2024-04-10 · Coloplast Manufacturing Us - Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400
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-0845-2025%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.