Basic Biopsy Tray (American Contract Systems) – Sterilization Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Basic Biopsy Tray, Item Number NMBP44L
Brand
American Contract Systems Inc.
Lot Codes / Batch Numbers
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
Products Sold
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
American Contract Systems Inc. is recalling Basic Biopsy Tray, Item Number NMBP44L due to Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026