American Contract Systems recalls medical convenience kits that were re-gassed (sterilized more than once) after a nonconformance during initial sterilization. These products may not be safe or effective due to unvalidated multiple sterilization cycles.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
American Contract Systems is recalling medical convenience kits that were re-gassed (sterilized more than once) after a problem occurred during the initial sterilization process. These kits may not be safe or effective because they haven't been validated for multiple sterilization cycles.
The kits were sterilized more than once after a problem occurred during the initial sterilization process. Because they haven't been validated for multiple sterilization cycles, their safety, quality, and effectiveness cannot be confirmed.
Medical professionals and hospitals that own or use these kits are most at risk. The specific products were sold to healthcare facilities and are used in medical procedures.
Check for the product codes listed in the recall: ANSH14AF (SHOULDER PACK), EVAH76H (ANTERIOR HIP PACK), FDSA15M (SHOULDER ARTHROSCOPY), and others. Look for the lot numbers and bag serial numbers provided in the recall notice.
Identify the specific product code and lot number from the recall list to confirm if your kit is affected.
The kits were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles.
The recall notice does not specify a remedy, so you should check the product details to see if your kit is affected and contact American Contract Systems for further instructions.
The recall states that product quality, safety, and effectiveness cannot be confirmed for kits that were re-gassed multiple times, but it does not specify a risk of injury or harm.
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-0184-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0184-2026 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.
