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
- Angio Pack / Angiography Pack
- Model numbers
- HSAN63N, IHAN02W, MHCA98AK, RCAN45C, UDCO10F
- 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
These are medical convenience kits used in angiography procedures. The packs are designed to streamline interventional imaging workflows in hospital settings.
Why This Is Dangerous
Re-gassing after EO sterilization means the devices may not have been validated for multiple sterilization cycles. This could compromise sterility and safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to quarantine affected packs and coordinate replacements. The recall is active and requires immediate attention from healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Verify model numbers against HSAN63N IHAN02W MHCA98AK RCAN45C UDCO10F
- Confirm whether the device has undergone a second EO sterilization cycle
- Refer to the recall notice for specific instructions and remedies
- Do not use affected devices until instructed otherwise by the manufacturer or healthcare facility leadership
- Document receipt of recall notice and actions taken
Where to find product info
FDA enforcement report Z-0180-2026 and the manufacturer recall notice linked in the enforcement action
What timeline to expect
Recall status is ACTIVE. Processing times for replacement or refunds will be provided by the manufacturer.
If the manufacturer is unresponsive
- Escalate to hospital compliance or risk management.
- If the manufacturer is unresponsive, contact the FDA consumer complaint coordinator or CPSC for guidance.
How to prevent similar issues
- Verify sterilization validation with suppliers.
- Require sterilization confirmation for EO cycles.
- Maintain updated recall communications and access to manufacturer contact information.
Documentation advice
Keep a copy of the recall notice, model numbers, serial/date codes, and all correspondence with the manufacturer.
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Product Details
Model numbers: HSAN63N, IHAN02W, MHCA98AK, RCAN45C, UDCO10F. Description: Medical convenience kits and angiography packs. Distribution: US nationwide in SD, IA, MN, WA, IL. Sold from: Unknown. Price: Unknown. Quantity recalled: 32,433.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Models: HSAN63N, IHAN02W, MHCA98AK, RCAN45C, UDCO10F
- Class II recall
- Distribution: United States (SD, IA, MN, WA, IL)
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Safety Guide
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