FDA Device recall Z-1344-2025
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 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-1344-2025 |
| 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
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
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 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-052911 |
|---|
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-1344-2025%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.