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 kits were re-gassed after a noncompliance during the Ethylene Oxide sterilization process. This raises concerns about their safety and effectiveness.

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 affects medical convenience kits with model number IHDC30R UDI-DI 191072226310, specifically lot 8096511. These kits were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois.

The Hazard

The affected products were re-gassed after failing the initial sterilization process. These kits have not been validated for multiple sterilization cycles, creating potential safety risks.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the potential for compromised product quality raises serious concerns.

What to Do

Patients and healthcare providers should stop using the recalled kits immediately. Follow the recall instructions provided by American Contract Systems or contact your healthcare provider for further guidance.

Contact Information

For more information, contact American Contract Systems Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0187-2026.

Key Facts

  • Recall date: September 4, 2025
  • Quantity: 32,433 kits
  • Distribution: SD, IA, MN, WA, IL
  • Model: IHDC30R UDI-DI 191072226310
  • Classification: Class II
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
IHDC30R UDI-DI 191072226310 lot 8096511 bag serial number N/A * If bag serial number is listed as "N/A"
then whole lot is affected
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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SUCRALFATE
CGMP Deviations:
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