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, PREGNANT, PETS
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
- Sterilization-reused medical kits
- Model numbers
- ANCV78BC, ANCV78BB UDI-DI 191072214362, HGCV05K, MHPP97AR, UDBH37AW, UHPP82AH, UICD62AN, UICT16F +2 more
- 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 kits used in clinical settings to supply cardiovascular procedures. They can include heart packs, CV setup packs, pacemaker packs, and vascular packs.
Why This Is Dangerous
Re-gassing after EO sterilization may affect sterility and effectiveness. Validation for multiple cycles is lacking.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to quarantine affected lots and reassess inventory impact.
Practical Guidance
How to identify if yours is affected
- Review item numbers and UDIs listed in recall.
- Check bag serial numbers where available.
- Cross-reference with distributor records.
Where to find product info
FDA enforcement page and recall notice; UDI-DI codes on packaging
What timeline to expect
Refunds or replacements processed through hospital procurement; typical timelines vary by institution
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA or CPSC for guidance
- Consult legal counsel if needed
How to prevent similar issues
- Implement single-cycle validated EO sterilization for kits
- Post reminders to procurement about sterilization validation
- Keep detailed records of sterilization cycles and lot numbers
Documentation advice
Keep product invoices, batch numbers, serials, and recall communications
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Product Details
Item numbers and descriptions include ANCV78BC HEART PACK 205947, HGCV05K CV SET UP PACK, MHPP97AR PACEMAKER PACK 206010, UDBH37AW BASIC HEART PACK 206044, UHPP82AH PERIPHERAL PACK 209533, UICD62AN CARDIOVASCULAR SUPPLY PS 907285, UICT16F CARDIO THORACIC DRAPE PACK PS 907284, UIVA75I VASCULAR PACK. Total quantity: 32,433 units. Distribution: US nationwide in SD, IA, MN, WA, IL.
Reported Incidents
No injury data provided in the recall notice. The FDA enforcement report lists the status as active with high hazard level.
Key Facts
- 32,433 total units recalled
- High hazard level
- Re-gassed after EO sterilization
- Not validated for multiple sterilization cycles
- Distributed nationwide in SD, IA, MN, WA, IL
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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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