American Contract Systems recalled 32,433 biopsy trays on September 4, 2025. The recall affects multiple models due to improper re-sterilization that raises safety concerns. Healthcare providers and patients must stop using these products immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall includes biopsy trays identified by item numbers AKRB26D, AMGL09AA, ANLC35AD, and others. These products were distributed nationwide across South Dakota, Iowa, Minnesota, Washington, and Illinois. Prices for these trays vary.
The products were re-gassed after a nonconformance during the Ethylene Oxide gas sterilization process. They have not been validated for multiple sterilization cycles, which poses a risk to product quality and safety.
No specific incidents have been reported in relation to this recall. However, the potential for compromised sterility raises serious safety concerns for users.
Stop using the affected biopsy trays immediately. Follow the recall instructions issued by the manufacturer and contact American Contract Systems or your healthcare provider for further instructions.
For additional inquiries, call American Contract Systems at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0171-2026.
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