FDA Medical devices recall ·
Medical convenience kits Item number/ Product description AKGN82E GENERAL… recall
- Recall number
- Z-0172-2026
- Date
- (initiated September 4, 2025)
- Company / brand
- American Contract Systems Inc
1601 Se Gateway Dr Ste 120, Grimes, IA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32,433 total
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448; AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042; ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117; ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621; CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706; CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A; EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257; EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868; FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258; FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897; HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067; HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A; HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513; IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038; IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486; IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149; LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A; LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A; LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780; MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A; NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A; OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial number
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States: Iowa Illinois Minnesota South Dakota Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0172-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.