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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Biopsy Tray
- Model numbers
- NMBP44L, UDI-DI 191072188120, Lot 8515411
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check item number NMBP44L
- Verify lot number 8515411
- 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
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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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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