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
- Orthopedic Surgical Kit
- Model numbers
- AMEX26AA, ANSH14AF, EVAH76H, FDSA15M, GRTS90G, HGHI26G, HJTO25C, HNEX60L +12 more
- 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 sterile orthopedic surgical kits used as part of surgical procedures. They are designed to contain multiple components for specific operations.
Why This Is Dangerous
Re-gassing after EO sterilization introduces uncertainty about sterility. Without validated exposure to multiple sterilization cycles, the safety and effectiveness of the kits cannot be guaranteed.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to replace affected kits. The recall may affect procurement and stock levels, with potential delays in procedures if replacements are not readily available.
Practical Guidance
How to identify if yours is affected
- Compare model numbers to the list of affected models.
- Check UDI-DI and lot numbers printed on the bags for cross-reference.
- Review the recall letter for exact instructions.
Where to find product info
Recall letter from American Contract Systems; FDA enforcement page linked in notice
What timeline to expect
Recall processing times are not specified; typical timelines range from weeks to months depending on replacements
If the manufacturer is unresponsive
- Escalate to hospital risk management or patient safety officer
- File a complaint with the supplier and document all communications
How to prevent similar issues
- Verify sterilization validation certificates before procurement
- Use EO sterilization processes only with validated cycles
- Maintain updated recall communications for all surgical kits
Documentation advice
Keep the recall letter, model numbers, serials, and any communications with the manufacturer; document any replacements or refunds
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Product Details
Model numbers and descriptions include AMEX26AA, ANSH14AF, EVAH76H, FDSA15M, GRTS90G, HGHI26G, HJTO25C, HNEX60L, IAHD53C, IASH65A, IHUE40AI, ILTJ47AA, LMHP14Z, LMSN44AE, MHHP25H, MHTH90AJ, MWAH32P, MWTK13AH, PLOR89H, RCUE81B. Sold nationwide in the United States, including SD, IA, MN, WA, IL. Specific price and sale dates are not provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- 20 affected model numbers
- States distributed to: SD, IA, MN, WA, IL
- Reason for recall: re-gassed EO sterilization, not validated for multiple cycles
- Action: stop using immediately; await recall letter for next steps
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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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