HIGH

American Contract Systems Recalls Biopsy Trays Due to Sterilization Issues

American Contract Systems recalled 32,433 biopsy trays on September 4, 2025. The recall affects multiple models due to improper re-sterilization that raises safety concerns. Healthcare providers and patients 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 recall includes biopsy trays identified by item numbers AKRB26D, AMGL09AA, ANLC35AD, and others. These products were distributed nationwide across South Dakota, Iowa, Minnesota, Washington, and Illinois. Prices for these trays vary.

The Hazard

The products were re-gassed after a nonconformance during the Ethylene Oxide gas sterilization process. They have not been validated for multiple sterilization cycles, which poses a risk to product quality and safety.

Reported Incidents

No specific incidents have been reported in relation to this recall. However, the potential for compromised sterility raises serious safety concerns for users.

What to Do

Stop using the affected biopsy trays immediately. Follow the recall instructions issued by the manufacturer and contact American Contract Systems or your healthcare provider for further instructions.

Contact Information

For additional inquiries, call American Contract Systems at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0171-2026.

Key Facts

  • Recall date: September 4, 2025
  • Total units recalled: 32,433
  • Safety classification: Class II
  • Distribution: Nationwide in SD, IA, MN, WA, IL
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 TypeBiopsy Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939
AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364
ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers 17556328 17556374 17556376 17556393
ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers 47862596 47862598
FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260
+9 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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