Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Cardiac Catheterization Kit
- Model numbers
- AMCL05P, EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH
- Sold at
- Unknown
- 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 used in cath lab procedures and include packs for left heart caths and angiography. They are designed for single-use in sterile environments.
Why This Is Dangerous
Re-gassing after EO sterilization may compromise sterility and device performance if cycles exceed validated limits.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience procedure delays or require alternate supplier arrangements while affected kits are identified and replacement materials are provided.
Practical Guidance
How to identify if yours is affected
- Check model numbers AMCL05P, EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH.
- Review UDI-DI data, lot numbers, and bag serial numbers shown in the recall listing.
- Quarantine any units that match the recall details.
Where to find product info
UDI-DI is printed on packaging; lot numbers and bag serial numbers are on the bag labels.
What timeline to expect
4-8 weeks for replacement or remediation after recall initiation.
If the manufacturer is unresponsive
- Escalate to hospital recall coordinator and consider contacting FDA MedWatch if no response.
- Document all outreach attempts and responses.
How to prevent similar issues
- Require sterilization processes to be validated for multiple cycles before use.
- Ask suppliers for EO sterilization validation documentation.
- Implement a robust inventory check to identify affected lots quickly.
Documentation advice
Keep recall letter, product labels, UDI-DI, lot numbers, and bag serial numbers. Photograph packaging and maintain an inventory list.
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Product Details
Model numbers include EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH, and AMCL05P. Items described as LEFT HEART CATH PACK, CATH LAB ANGIO, CATH CARDIAC PACK, CARDIAC CATH TRINITY, CARDIAC CATH ANGIO PACK, and RADIAL PACK. US nationwide distribution to healthcare providers, with state distribution listed as SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Quantity: 32,433 units. Manufacturer: American Contract Systems. No consumer retailers identified. Price information not provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- Models: AMCL05P, EVLH67F, FDCL22R, IHCC03X, TNCC02AD, UICC27AG, UIRD89AH
- Nationwide distribution to SD, IA, MN, WA, IL
- Recall date 2025-09-04; Report date 2025-10-22
- No injuries or incidents reported
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Safety Guide
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