FDA Device recall Z-1173-2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397
- FDA Device
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397 by Medline Industries Northfield, citing medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1173-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-03 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | CA |
Product
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Reason
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Identifiers
| code_info | UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2025%22
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