Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Medical instrument kit / medical device pack
- Model numbers
- AKGN82E, AMCB08Y, ANBP10AC, ANIR77AM, CFLA39G, CIBL33I, EVMN24E, EVST48E +24 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Medical convenience kits are bundled supplies used by hospitals and clinics to support a range of procedures. They include various pack components designed for sterile environments.
Why This Is Dangerous
The EO sterilization process for these items did not pass a re-sterilization validation, meaning repeated sterilization could compromise quality and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to halt procedures using these kits until replacements are obtained. The recall may affect supply chains for sterile procedure packs and could delay certain medical activities.
Practical Guidance
How to identify if yours is affected
- Review item numbers listed in the recall notice.
- Check UDI-DI and lot numbers printed on each kit’s bag and packaging.
- Compare your inventory to the affected model list.
Where to find product info
Identify UDI-DI, lot numbers, and bag serial numbers on the kit packaging and labels.
What timeline to expect
4-8 weeks for recall remedy processing and replacement instructions.
If the manufacturer is unresponsive
- Document every contact attempt.
- Escalate to hospital risk management and FDA if the supplier does not respond within a reasonable period.
How to prevent similar issues
- Verify sterilization validation for reused medical devices.
- Prefer single-use sterile packs when possible.
- Keep a current inventory of medical device packs and monitor recall notices.
Documentation advice
Save all recall notices, photos of labels, serial numbers, and all correspondence with the supplier.
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Product Details
Model numbers involved: AKGN82E, AMCB08Y, ANBP10AC, ANIR77AM, CFLA39G, CIBL33I, EVMN24E, EVST48E, FDTA11AA, FHHY25P, HGML99G, HGXR41H, HISU54M, IHAA19AP, IHMP89K, IHPD14AM, LKVG10O, LMAG20G, LMLE46AA, MIEN58A, NUMB04H, OWBS11U, RCMS71B, SFMB55X, STBA09F, TNBS21O, UDBH37AX, UDMA50X, UICR54W, UIPC89D, UIPT13F, UISB96AB. Distribution: US nationwide. Sold to hospitals and medical facilities. Recall date: 2025-09-04. Sold price: Unknown. Quantity: 32,433 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32 item numbers listed
- US nationwide distribution in SD, IA, MN, WA, IL
- Re-gassed after EO sterilization nonconformance; not validated for multiple cycles
- Class II recall; high-hazard device
- Recall date 2025-09-04; Report date 2025-10-22
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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