FDA Device recall Z-1345-2025
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 by American Contract Systems, citing ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1345-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-06 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Reason
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Identifiers
| code_info | UDI-DI 00191072136688 Lots 905241 70-050739 70-051020 70-051480 70-051606 70-051888 |
|---|
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-1345-2025%22
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