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 convenience kit
- Model numbers
- IHDC30R UDI-DI 191072226310 lot 8096511 bag serial number N/A
- 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
These are medical convenience kits used in clinical settings. They are intended to support routine medical workflows and patient care.
Why This Is Dangerous
Re-gassing after the EO sterilization process was not validated for multiple cycles. This raises concerns about the device meeting intended safety and effectiveness standards.
Industry Context
This recall is not presented as part of a broader industry pattern in the available information.
Real-World Impact
Hospitals and clinics may need to halt use of affected lots and coordinate with suppliers for replacement options. The recall may affect care delivery relying on these kits.
Practical Guidance
How to identify if yours is affected
- Confirm model IHDC30R UDI-DI 191072226310
- Check lot number 8096511
- Check bag serial number; if N/A, the whole lot is affected
- Compare to recall notice and FDA report
Where to find product info
Recall notices, FDA enforcement page Z-0187-2026, and manufacturer instructions
What timeline to expect
No refunds info provided in the data; follow the recall notification by letter for guidance on next steps
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA CPSC for guidance on consumer rights
- Document communications and seek escalation if no response from manufacturer
How to prevent similar issues
- Verify sterilization validation with suppliers
- Ask manufacturers for EO sterilization validation data
- In future purchases, require EO sterilization validation and lot-specific documentation
Documentation advice
Keep copy of recall notices, lot numbers, model numbers, and correspondence with manufacturer
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Product Details
IHDC30R D AND C PACK medical convenience kits. Model: IHDC30R UDI-DI 191072226310. Lot: 8096511. Bag serial: N/A (bag serial listed as N/A means the whole lot is affected). Sold in the US nationwide with distribution in SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Manufacturer: American Contract Systems Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- Recall date 2025-09-04; report date 2025-10-22
- Distribution states: SD, IA, MN, WA, IL
- Model: IHDC30R UDI-DI 191072226310
- Lot: 8096511; bag serial number N/A indicates whole lot affected
- Hazard: re-gassed EO sterilized after nonconformance; not validated for multiple cycles
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Safety Guide
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