American Contract Systems recalled 32,433 basic biopsy trays distributed nationwide in the United States. These trays were re-gassed after a nonconformance occurred during the initial Ethylene Oxide gas injection. The trays have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using affected trays and follow recall instructions.
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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Biopsy trays are used to hold tissue samples during surgical procedures. These trays are sterilized and packaged for single-use or limited reuse in operating rooms.
Re-gassed trays have not been validated for repeated sterilization cycles. Using them could compromise sterility, safety, and effectiveness in clinical settings.
This recall is not described as part of a broader industry pattern.
Hospitals and surgical centers may need to replace affected trays. The recall could affect operating room supply chains and procurement records.
Refer to the FDA enforcement page linked in the recall notice for model and lot details
No timeline is provided for remediation or replacement in the recall notice
Keep recall letter, inventory listings, and supplier communications as part of the chain-of-custody records
Model numbers/descriptions include AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571). The reason: re-gassed after EO sterilization nonconformance.
No injuries or incidents have been reported.
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