American Contract Systems recalls LAPAROSCOPY PACK models CALS41F and CALS41G due to possible failure in sterilization assurance, which may cause treatment delays or prolonged procedures.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling laparoscopy packs with model numbers CALS41F, CALS41F-01, and CALS41G because they may not have been properly sterilized. This could lead to delays or longer treatment times for patients needing surgery.
The packs may not have been sterilized correctly, which could mean they are not safe for use in surgery. This might cause treatment delays or longer procedures if the packs are used without proper sterilization.
Healthcare professionals using laparoscopy packs for surgical procedures are likely affected. Patients undergoing surgery may experience delays or longer procedures if the packs are not properly sterilized.
Check for model numbers CALS41F, CALS41F-01, or CALS41G on the laparoscopy packs. The packs were sold with specific tray lots and UDI-DI numbers listed in the recall notice.
Identify the model number on the laparoscopy pack to see if it matches CALS41F, CALS41F-01, or CALS41G.
American Contract Systems cannot confirm that the laparoscopy packs were properly sterilized, which may cause treatment delays or prolonged procedures.
The recall does not specify a remedy, so check the model number to see if it is affected and contact the manufacturer for further instructions.
The recall states that improper sterilization could lead to treatment delays or longer procedures, but it does not mention patient injury.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1331-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1331-2025 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
