American Contract Systems recalls Basic Biopsy Trays that were re-gassed after initial sterilization. These products may not be safe or effective due to 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 certain Basic Biopsy Trays that were re-gassed (sterilized more than once) after a problem during initial sterilization. This could mean the trays are unsafe or ineffective for medical use.
The trays were re-gassed after a nonconformance during the initial sterilization process. This means they were sterilized more than once without proper validation, so their safety and effectiveness cannot be confirmed.
Healthcare professionals using these trays in surgeries or medical procedures are most at risk. Patients receiving procedures with these trays may be affected.
Check for model numbers like AKRB26D, AMGL09AA, or ANLC35AD on the tray. Look for specific lot numbers and bag serial numbers listed in the recall notice.
Identify the model number and lot information on the tray to confirm if it's affected by this recall.
The trays were re-gassed after a problem during initial sterilization, which means they were sterilized more than once without proper validation.
Check for specific model numbers like AKRB26D, AMGL09AA, or ANLC35AD along with the lot numbers and bag serial numbers listed in the recall notice.
The recall does not specify a remedy, so contact American Contract Systems for further instructions.
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-0171-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0171-2026 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.
