HIGH

American Contract Systems Recalled 32,433 Orthopedic Surgical Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide in SD, IA, MN, WA and IL. The devices were re-gassed after a nonconformance in the Ethylene Oxide sterilization process. The sterilization cycles have not been validated, so quality, safety and effectiveness cannot be confirmed. Consumers and healthcare providers should stop using the kits

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

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

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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

  1. Compare model numbers to the list of affected models.
  2. Check UDI-DI and lot numbers printed on the bags for cross-reference.
  3. 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

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
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOrthopedic Surgical Kit
Sold At
Multiple Retailers

Product Details

Model Numbers
AMEX26AA
ANSH14AF
EVAH76H
FDSA15M
GRTS90G
+15 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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