Basic Biopsy Tray; Item Number/Description: 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)
FDA Recall Z-0171-2026 · Posted 2025-10-16
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Recalling FirmAmerican Contract Systems Inc.
Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2025-09-04
Product Quantity32,433 total
Reason for Recall
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.
Firm Action
Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.
Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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