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
- Surgical sterilization kit
- Model numbers
- FHCP08Y, HICS50I, HSCB90B
- 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 intended to provide sterile packs for obstetric procedures, including cesarean sections. They are used in operating room or hospital settings by healthcare professionals.
Why This Is Dangerous
Re-gassing after a nonconformance during EO sterilization may affect sterility, safety, and effectiveness. The products have not been validated for exposure to multiple sterilization cycles.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals may need to halt use of affected kits, re-check inventory, and coordinate with the manufacturer for guidance on replacements or refunds. Potential risk to patients if compromised sterility is used in procedures.
Practical Guidance
How to identify if yours is affected
- Identify model numbers FHCP08Y, HICS50I, HSCB90B on packaging or labeling.
- Match UDI-DI numbers 191072232724, 191072212351, 191072141606 and associated lot numbers.
- If bag serial numbers are provided, verify listed serials; if bag serial is listed as N/A, the whole lot is affected.
Where to find product info
Refer to the recall notice and the FDA enforcement page for Z-0181-2026; manufacturer communications will include specifics.
What timeline to expect
Replacements or refunds, if offered, will be communicated by the manufacturer. Timeline varies by facility and recall response plan.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management if the supplier is unresponsive.
- Consider contacting the FDA for guidance if the issue remains unresolved.
How to prevent similar issues
- Verify sterilization validation before re-using EO-sterilized devices.
- Ask suppliers for validated EO sterilization cycles and lot-specific certificates.
- Maintain an auditable recall process and inventory controls for sterilized medical kits.
Documentation advice
Keep the recall notice, supplier communications, inventory logs, and any returned items documentation for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Medical convenience kits. Item Numbers: FHCP08Y (C SECTION PK), HICS50I (C-SECTION PACK), HSCB90B (C-SECTION BASIN PACK). UDI-DI: FHCP08Y 191072232724, HICS50I 191072212351, HSCB90B 191072141606. Lot numbers: 8216211, 8161711, 8083511. Quantity: 32,433 total. Sold to: Healthcare facilities nationwide. States listed for distribution: SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Status: ACTIVE. Manufacturer: American Contract Systems Inc. Recall number: Z-0181-2026. Distribution: US nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- Models affected: FHCP08Y, HICS50I, HSCB90B
- States of distribution: SD, IA, MN, WA, IL
- Recall date: 2025-09-04 with active status
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.