HIGH

American Contract Systems Basic Biopsy Tray Recalled for Re-Gassing Hazard (32,433 Units) 2025Recall

American Contract Systems recalled 32,433 Basic Biopsy Trays nationwide after discovering re-gassing occurred following a nonconformance during Ethylene Oxide sterilization. The trays have not been validated for exposure to multiple sterilization cycles, so product quality and safety cannot be confirmed. Healthcare providers and patients should stop using the device immediately and follow theメーカー?

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

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About This Product

The Basic Biopsy Tray is a disposable tool used in medical procedures to collect tissue samples. It is typically employed in clinical or hospital settings under sterile conditions.

Why This Is Dangerous

The hazard arises because some units were re-gassed after a nonconformance in EO sterilization. The products have not been validated for exposure to multiple sterilization cycles, so quality, safety, and effectiveness cannot be confirmed.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may need to quarantine affected lots and switch to alternative trays. The recall is active and affects thousands of units.

Practical Guidance

How to identify if yours is affected

  1. Check item number NMBP44L
  2. Verify lot number 8515411
  3. Check UDI-DI 191072188120
  4. If matched, stop using the tray and follow recall instructions

Where to find product info

FDA enforcement page and manufacturer recall notification for instructions

What timeline to expect

Not specified in the recall notice

If the manufacturer is unresponsive

  • Document outreach attempts and escalate to FDA if the manufacturer is unresponsive
  • Consider filing a consumer complaint with FDA if no guidance is received within a reasonable time

How to prevent similar issues

  • Verify EO sterilization validation and lot traceability before purchase
  • Request sterilization validation data from suppliers
  • Maintain strict sterilization records for medical devices
  • Source medical device trays from reputable suppliers with recall history checks

Documentation advice

Keep the recall notice, batch/lot information, shipping records, and all correspondences with the manufacturer for records

Product Details

Product: Basic Biopsy Tray Item Number: NMBP44L Brand/Manufacturer: American Contract Systems UDI-DI: 191072188120 Lot: 8515411 Quantity: 32,433 Distribution: US nationwide in SD, IA, MN, WA, IL Sold at: Unknown Price: Unknown Sold since: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 total units recalled
  • Health care settings and patients potentially affected
  • NMBP44L is the model in question
  • EO sterilization re-gassing is the root cause
  • Active FDA recall page: Z-0170-2026
View Original Recall on FDA - Medical Devices

Browse More Recalls

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeBiopsy Tray
Sold At
Multiple Retailers

Product Details

Model Numbers
NMBP44L
UDI-DI 191072188120
Lot 8515411
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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