American Contract Systems recalls Basic Biopsy Tray (NMBP44L) due to potential re-gassing during sterilization, risking product safety and effectiveness.
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 Basic Biopsy Trays (Item NMBP44L) because they were re-gassed more than once during sterilization. This could mean the trays aren't safe or effective for medical use.
The trays were re-gassed (sterilized) more than once after a problem occurred during the initial sterilization process. This means the product quality, safety, and effectiveness cannot be confirmed.
Healthcare professionals using these trays in medical settings are most at risk. Patients and staff handling the trays during procedures may be affected.
Check for the item number NMBP44L on the tray. The entire lot with UDI-DI 1910721:88120 and lot number 8515411 is affected.
Look for the item number NMBP44L and UDI-DI 191072188120 lot 8515411 on the tray.
The trays were re-gassed more than once during sterilization, which means their safety and effectiveness cannot be confirmed.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates potential issues with product safety and effectiveness, but no specific injury risk is described.
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-0170-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0170-2026 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.
