Basic Biopsy Tray — Class II medical device recall Z-0171-2026

Ongoing recall by American Contract Systems Inc., reported 2025-10-22, distributed nationwide. Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the init

Recall number	`Z-0171-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	American Contract Systems Inc., Grimes, IA, United States
Recall initiated	2025-09-04
Classified	2025-10-16
Reported by FDA	2025-10-22
Distributed	Nationwide (US)
Quantity	32,433 total
Reason classes	chemical contamination
UPC / GTIN / UDI-DI	`00191072203519`, `00191072207357`, `00191072211477`, `00191072214072`, `00191072223029`, `00191072226303`, `00191072226372`, `00191072229366`, `00191072235565`, `00191072235930`, `00191072236333`, `00191072236500`, `00191072236531`
Lot numbers	`7350411`, `8021911`, `8096211`, `8107911`, `8134111`, `8150511`, `8173811`, `8192711`, `8195611`, `8230311`, `8306311`, `8319311`, `8322811`, `8459111`, `8501711`, `8527411`
Serial numbers	`17488260`, `17556328`, `17556374`, `17556376`, `17556393`, `17744347`, `47862596`, `47862598`, `68195543`, `68196275`, `68198164`, `68198213`, `68198222`, `68198228`, `68198229`, `68236939`, `68244060`, `68277361`, `68596086`, `68678361`, `68678364`, `68873222`, `AMGL09AA`, `ANLC35AD`, `ANLP25AJ` and 9 more

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)

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0171-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.