HIGH

American Contract Systems Biopsy Tray Recalled Over Sterilization Issues

American Contract Systems recalled 32,433 Basic Biopsy Trays on September 4, 2025. The recall resulted from products being re-gassed after a sterilization failure. The company cannot confirm the safety or effectiveness of these devices after 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 recalled product is the Basic Biopsy Tray, Item Number NMBP44L. The entire lot impacted is UDI-DI 191072188120 Lot 8515411. These trays were distributed nationwide across South Dakota, Iowa, Minnesota, Washington, and Illinois.

The Hazard

The recall stems from a nonconformance during the initial Ethylene Oxide gas injection process. Products were re-gassed, which violates sterilization protocols, raising concerns about their quality and safety.

Reported Incidents

No specific incidents of injury or death related to this recall have been reported. The high hazard classification indicates potential serious risks associated with using the device.

What to Do

Stop using the Basic Biopsy Tray immediately. Follow the recall instructions provided by American Contract Systems. Contact the manufacturer or your healthcare provider for further guidance.

Contact Information

For further assistance, contact American Contract Systems Inc. via their website or the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0170-2026.

Key Facts

  • Recalled product: Basic Biopsy Tray, Item Number NMBP44L
  • Quantity: 32,433 units
  • Recall issued on September 4, 2025
  • Distribution included SD, IA, MN, WA, IL
  • Stop use 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 TypeBiopsy Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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