Reported Mar 26, 2025 · Ongoing
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
LAPAROSCOPY PACKModel No. CALS41FCALS41F-01CALS41G
- Lot codes and dates
- 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
- Amount recalled
- 303 kits
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
- OH
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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