FDA Device recall Z-1337-2025
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-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-1337-2025 |
| 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
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-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 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048 |
|---|
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-1337-2025%22
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