HIGH

American Contract Systems Recalls Medical Convenience Kits Due to Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall stems from products being re-gassed after a nonconformance during sterilization. This compromises the quality and safety of the devices.

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

Product Details

The recall includes various models such as ANSH14AF Shoulder Pack and EVAH76H Anterior Hip Pack. The products were distributed nationwide in states including SD, IA, MN, WA, and IL. They were sold at multiple retailers.

The Hazard

The affected products were re-gassed after failing the initial Ethylene Oxide gas injection process. These products have not been validated for safety after multiple sterilization cycles.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the risk associated with unvalidated sterilization poses a high concern.

What to Do

Stop using the recalled medical kits immediately. Contact American Contract Systems or your healthcare provider for further instructions on the recall process.

Contact Information

For more information, call American Contract Systems or visit their website. Detailed recall instructions are also available in the notification letter.

Key Facts

  • Recall date: September 4, 2025
  • Total units recalled: 32,433
  • Distribution: US Nationwide
  • Manufacturer: American Contract Systems
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeMedical Convenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A
ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192
EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760
FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299
GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A
+15 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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