LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G recallZ-1331-2025 · American Contract Systems Inc · initiated Feb 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Contract Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1331-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2025
- Posted by the FDA
- Mar 14, 2025
- Recalling firm
- American Contract Systems Inc
- Quantity
- 303 kits
- Product code
- FDE
- Distribution
- US Nationwide distribution in the state of OH.
Product description
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ACS CALS41FAmerican Contract Systems, Inc. · laparoscopy kit1 recall0 reports
- ACS CALS41GAmerican Contract Systems, Inc. · laparoscopy kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96343).
- Z-1332-2025 · Open, ClassifiedDR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
- Z-1333-2025 · Open, ClassifiedHIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
- Z-1334-2025 · Open, ClassifiedMAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
- Z-1335-2025 · Open, ClassifiedCYSTO PACK , Model N. HKCY31A
- Z-1336-2025 · Open, ClassifiedC-SECTION PACK, Model Nos LLCS44F LLCS44F-01
- Z-1337-2025 · Open, ClassifiedLAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
- Z-1338-2025 · Open, ClassifiedLABOR & DELIVERY PACK, Model Nos LLLD19H
- Z-1339-2025 · Open, ClassifiedOPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
- Z-1340-2025 · Open, ClassifiedGENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
- Z-1341-2025 · Open, ClassifiedBORN ON ARRIVAL KIT , Model No LLBN11B
- Z-1342-2025 · Open, ClassifiedC-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
- Z-1343-2025 · Open, ClassifiedCENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
- Z-1344-2025 · Open, ClassifiedLABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
- Z-1345-2025 · Open, ClassifiedURO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
- Z-1346-2025 · Open, ClassifiedCYSTO , Model No SACY80R
- Z-1347-2025 · Open, ClassifiedTOTAL HIP PACK , Model No SMTH06O SMTH06P
- Z-1348-2025 · Open, ClassifiedDELIVERY PACK , Model No SGDV22D-01 SGDV22E
- Z-1349-2025 · Open, ClassifiedLACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
- Z-1350-2025 · Open, ClassifiedLACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
- Z-1351-2025 · Open, ClassifiedEAR PACK , Model No SFEA12A
- Z-1352-2025 · Open, ClassifiedLAPAROSCOPY PACK , Model No SFLA02A SFLA02B
- Z-1354-2025 · Open, ClassifiedDIAGNOSTIC NEURO IR TRAY , Model No WENE21
- Z-1355-2025 · Open, ClassifiedNEURO IR TRAY , Model No WENI56J
- Z-1356-2025 · Open, ClassifiedAV FISTULA , Model No UTAV77T
- Z-1357-2025 · Open, ClassifiedGENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
- Z-1358-2025 · Open, ClassifiedMAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
- Z-1359-2025 · Open, ClassifiedOPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
- Z-1360-2025 · Open, ClassifiedSPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
- Z-1361-2025 · Open, ClassifiedTHORACIC PACK , Model No UTTC82Y UTTC82AA-01
- Z-1362-2025 · Open, ClassifiedVEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page