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 follows the identification of products that were re-gassed after sterilization failures. The safety and effectiveness of these products cannot be confirmed due to multiple sterilization cycles.

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 the following products: HEART PACK (ANCV78BC), CV SET UP PACK (HGCV05K), PACEMAKER PACK (MHPP97AR), BASIC HEART PACK (UDBH37AW), and others. These kits were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois.

The Hazard

The kits were found to have been sterilized more than once after a failure in the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for safety and effectiveness for multiple sterilization cycles.

Reported Incidents

No specific injuries or incidents have been reported related to this recall. The hazard level is classified as high due to the potential risks associated with using non-validated medical products.

What to Do

Patients and healthcare providers must stop using these medical kits immediately. Follow the recall instructions provided by the manufacturer or contact American Contract Systems for further guidance.

Contact Information

For more information, contact American Contract Systems Inc. or visit the FDA recall notice at: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0176-2026.

Key Facts

  • 32,433 medical kits recalled
  • Sterilization process failed
  • High hazard level
  • Stop using immediately
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
ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380
ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A
HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464
MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A
UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335
+6 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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