Device recall: LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Class II FDA enforcement event 96343. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
American Contract Systems Inc started this device recall on 6 Feb 2025. The firm address in the FDA record is in Tiffin, OH. FDA put the recall in Class II. FDA event 96343 has 32 product records. The first FDA enforcement report date is 26 Mar 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the state of OH.
Recalling firm
American Contract Systems Inc, Tiffin, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
32 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1331-2025 | LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G | 303 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1332-2025 | DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 | 1200 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1333-2025 | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 | 388 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1334-2025 | MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H | 17 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1335-2025 | CYSTO PACK , Model N. HKCY31A | 36 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1336-2025 | C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 | 252 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1337-2025 | LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02 | 630 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1338-2025 | LABOR & DELIVERY PACK, Model Nos LLLD19H | 725 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1339-2025 | OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I | 90 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1340-2025 | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 | 956 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1341-2025 | BORN ON ARRIVAL KIT , Model No LLBN11B | 54 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1342-2025 | C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 | 1106 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1343-2025 | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 | 1420 | Class II | Ongoing | 26 Mar 2025 |
| Z-1344-2025 | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 | 1836 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1345-2025 | URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 | 41 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1346-2025 | CYSTO , Model No SACY80R | 144 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1347-2025 | TOTAL HIP PACK , Model No SMTH06O SMTH06P | 24 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1348-2025 | DELIVERY PACK , Model No SGDV22D-01 SGDV22E | 36 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1349-2025 | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B | 690 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1350-2025 | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B | 690 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1351-2025 | EAR PACK , Model No SFEA12A | 51 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1352-2025 | LAPAROSCOPY PACK , Model No SFLA02A SFLA02B | 237 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1353-2025 | CV BASIC PUMP PACK , Model No WECV23D | 134 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1354-2025 | DIAGNOSTIC NEURO IR TRAY , Model No WENE21 | 170 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1355-2025 | NEURO IR TRAY , Model No WENI56J | 120 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1356-2025 | AV FISTULA , Model No UTAV77T | 90 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1357-2025 | GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 | 534 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1358-2025 | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02 | 147 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1359-2025 | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 | 54 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1360-2025 | SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB | 106 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1361-2025 | THORACIC PACK , Model No UTTC82Y UTTC82AA-01 | 40 kits | Class II | Ongoing | 26 Mar 2025 |
| Z-1362-2025 | VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 | 48 kits | Class II | Ongoing | 26 Mar 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 32Median of the firm: 4
- Events of the firm on the register
- 22
Other events of the firm
Official channels
- FDA enforcement report Z-1331-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96343. https://recallregister.com/fda/ii/96343/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the state of OH.
- What quantity of product is in FDA event 96343?
- The event has 32 product records. The first record gives this quantity:
303 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.