HIGH

American Contract Systems Recalls Medical Kits Over Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall affects various models due to improper sterilization processes. Patients and healthcare providers must stop using these products immediately.

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 recalled products include various medical kits such as the General Pack (AKGN82E) and Chest Breast Pack (AMCB08Y). They were distributed nationwide, particularly in South Dakota, Iowa, Minnesota, Washington, and Illinois.

The Hazard

The kits were re-gassed after a nonconformance during the initial Ethylene Oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles.

Reported Incidents

There are currently no reported injuries or incidents associated with these recalled products. The potential for compromised safety and effectiveness exists.

What to Do

Stop using the recalled medical kits immediately and follow the recall instructions provided by American Contract Systems. Contact your healthcare provider for further instructions.

Contact Information

For more details, contact American Contract Systems Inc. at the provided manufacturer contact number. Additional information is available on the FDA recall website.

Key Facts

  • Recall date: September 4, 2025
  • Total quantity recalled: 32,433 units
  • Distribution: US Nationwide
  • Hazard level: High
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
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448
AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042
ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117
ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621
CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706
+15 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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