Basic Biopsy Tray, Item Number NMBP44L
This recall is currently active, issued October 16, 2025. It was issued by American Contract Systems Inc..
- Company
- American Contract Systems Inc.
- Recall Initiated
- September 4, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0170-2026
- Quantity
- 32,433 total
- Firm Location
- Grimes, IA
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Lot / Code Info
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
Root Cause
Nonconforming Material/Component
Action Taken
Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.