FDA Device recall Z-1331-2025
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G 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-1331-2025 |
| 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 No. CALS41F, CALS41F-01, CALS41G
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 | 1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI…1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051 |
|---|
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-1331-2025%22
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