FDA Medical Device Recalls (openFDA)
American Contract Systems Inc: LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
- Recall number
- Z-1331-2025
- Recalling firm
- American Contract Systems Inc
- Product
- LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
- Status
- Open, Classified
- Initiated
- 2025-02-06
- Posted
- 2025-03-14
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
- Quantity
- 303 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- Firm FEI
- 3008492337
- Firm city
- Tiffin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28