Basic Biopsy Tray, Item Number NMBP44L
Reported: October 22, 2025 Initiated: September 4, 2025 #Z-0170-2026
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.
Details
- Recalling Firm
- American Contract Systems Inc.
- Units Affected
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Location
- Grimes, IA
Frequently Asked Questions
What product was recalled? ▼
Basic Biopsy Tray, Item Number NMBP44L. Recalled by American Contract Systems Inc.. Units affected: 32,433 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0170-2026.
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