Z-0170-2026 Class II Ongoing
FDA device recall Z-0170-2026 was initiated by American Contract Systems Inc. on Sep 4, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 32,433 total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 22, 2025
- Initiation Date
- Sep 4, 2025
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0170-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026