American Contract Systems recalls medical procedure kits with model numbers CILC69L, HNLC80J, JKLC55H, LLLA21K, and MPGL15G due to unverified sterilization status. Products may not be safe for use after sterilization.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling five types of medical procedure kits and trays because some components cannot be properly sterilized according to their procedures. This means the products may not meet safety standards for medical use, potentially risking infection or contamination during procedures.
The recall is based on ACS's internal finding that some components were not properly sterilized as per their procedures. This could mean the products do not meet safety standards for medical use, potentially leading to infection or contamination if used without proper sterilization.
Healthcare professionals and medical facilities that own or use the recalled medical procedure kits and trays. Those most at risk are users who may have been exposed to unsterilized components during procedures.
Check for model numbers: CILC69L, HNLC80J, JKLC55H, LLLA21K, or MPGL15G. Look for specific lot numbers listed in the recall notice for each model.
Identify the model number on your medical procedure kit or tray to see if it matches the recalled models: CILC69L, HNLC80J, JKLC55H, LLLA21K, or MPGL15G.
Reach out to American Contract Systems for further guidance on the recall and potential next steps.
American Contract Systems determined that some components were not properly sterilized according to their procedures, so they cannot confirm the products meet sterilization safety standards.
The recalled models are: LAP CHOLE PACK (CILC69L, HNLC80J, JKLC55H), LAPAROSCOPY PACK (LLLA21K), and GENERAL LAPAROSCOPY MPH (MPGL15G).
The recall does not require immediate discontinuation; however, users should check if their product is affected and contact the manufacturer for guidance.
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-2465-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2465-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
