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Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BRE...

FDA Device Recall #Z-0172-2026 — Class II — September 4, 2025

Recall Summary

Recall Number Z-0172-2026
Classification Class II — Moderate risk
Date Initiated September 4, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Contract Systems Inc.
Location Grimes, IA
Product Type Devices
Quantity 32,433 total

Product Description

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.

Distribution Pattern

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Lot / Code Information

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 numbers 47507802 47508002 47508012; RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A; SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A; SFMB55Y UDI-DI 191072229991 Lot 8096711 Bag serial number N/A Lot 8179711 Bag serial numbers 17556181 17557278; STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128; TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A; UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number 68703044; UDMA50X UDI-DI 191072172587 Lot 8084711 Bag serial number 17390548 Lot 8183611 Bag serial number 17554620; UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A; UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A; UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422; UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A * If "N/A" for bag serial number, then whole lot is affected

Other Recalls from American Contract Systems Inc.

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Z-0185-2026 Class II Medical convenience kits Item Number/Descri... Sep 4, 2025
Z-0174-2026 Class II Medical convenience kits Item Number/Descri... Sep 4, 2025
Z-0173-2026 Class II Medical convenience kits Item number/ Produ... Sep 4, 2025
Z-0187-2026 Class II Medical convenience kits IHDC30R D AND C PACK Sep 4, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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