Class 2 Device Recall American Contract Systems

• Date Initiated by Firm: September 04, 2025
• Date Posted: October 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0171-2026
• Recall Event ID: 97659
• Product Classification: laparoscopy kit - Product Code FDE
• Product: 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)
• Code Information: AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939; AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364; ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers 17556328 17556374 17556376 17556393; ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers 47862596 47862598; FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260; IHDA88AH UDI-DI 191072226303 Lot 8096211 Bag serial number N/A Lot 8150511 Bag Serial number 68277361; IHLC11AE UDI-DI 191072226372 Lot 8107911 Bag Serial Number N/A Lot 8192711 Bag Serial Numbers 68195543 68196275; MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222; MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086; RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A; SMLC53C UDI-DI 191072223029 Lot 8195611 Bag serial numbers 68198164 68198213 68198222 68198228 68198229; UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347; UIRU84AE UDI-DI 191072235565 Lot 8319311 Bag serial number 68244060 * If "N/A" for bag serial number, then whole lot is affected
• Recalling Firm/ Manufacturer: American Contract Systems Inc.; 1601 Se Gateway Dr Ste 120; Grimes IA 50111-5223
• For Additional Information Contact: Marlene Jones; 470-280-4277
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 32,433 total
• Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.