Medical convenience kits Item number/ Product description AKGN82E… — Class II medical device recall Z-0172-2026

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-0172-2026`
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	`00191072107121`, `00191072157256`, `00191072158666`, `00191072158680`, `00191072159236`, `00191072159960`, `00191072172587`, `00191072185082`, `00191072186409`, `00191072199775`, `00191072202895`, `00191072203496`, `00191072205742`, `00191072205797`, `00191072208798`, `00191072212399`, `00191072212580`, `00191072212672`, `00191072214300`, `00191072214843`, `00191072215093`, `00191072217851`, `00191072224064`, `00191072224187`, `00191072226150` and 8 more
Lot numbers	`7352211`, `7366711`, `7950311`, `7956111`, `7957411`, `7964411`, `7969611`, `7971211`, `7993111`, `8024811`, `8031711`, `8035011`, `8044011`, `8049111`, `8069411`, `8069911`, `8079711`, `8084711`, `8096711`, `8115211`, `8118411`, `8125811`, `8142811`, `8147011`, `8179711`, `8180911`, `8183611`, `8184711`, `8285311`, `8316911`, `8394711`, `8432911`, `8454211`, `8484911`, `8500811`, `8522811`
Serial numbers	`17390548`, `17427513`, `17487164`, `17488117`, `17506128`, `17554620`, `17556181`, `17557278`, `47384448`, `47507802`, `47508002`, `47508012`, `47864258`, `58588193`, `58588194`, `68047422`, `68048038`, `68117042`, `68152897`, `68154486`, `68194868`, `68198257`, `68200149`, `68244067`, `68563615` and 36 more

Product

Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)

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-0172-2026. 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.