Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223
Is this the product you have?
- 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)
- Lot codes and dates
33 of 33 products
Products covered by this recall # Barcodes Product as published 1 191072229281AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448 2 191072185082AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042 3 191072214300ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117 4 191072236692ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621 5 191072203496CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706 6 191072186409CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A 7 191072215093EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257 8 191072224064EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868 9 191072159236FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258 10 191072157256FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897 11 191072212580HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067 12 191072212672HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A 13 191072212399HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513 14 191072224187IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038 15 191072159960IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486 16 191072227232IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149 17 191072158666LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A 18 191072158680LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A 19 191072237880LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780 20 191072231444MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A - Amount recalled
- 32,433 total
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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