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Basic Biopsy Tray recallZ-0171-2026 · American Contract Systems Inc. · initiated Sep 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0171-2026
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
American Contract Systems Inc.
Quantity
32,433 total
Product code
FDE
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Product description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

13 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97659).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page