Basic Biopsy Tray, Item Number NMBP44L

FDA device recall Z-0170-2026 · posted 2025-10-16 · Open, Classified

Recall details

Recalling firm

American Contract Systems Inc.

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FCH

Quantity affected

32,433 total

Distribution

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Date initiated

2025-09-04

Date posted

2025-10-16

Location

Grimes, IA