Z-0170-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,433 total
Product Description
Basic Biopsy Tray, Item Number NMBP44L
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Code Information
UDI-DI 191072188120 Lot 8515411 Entire lot impacted