Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205
FDA device recall Z-0171-2026 · 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
- FDE
- 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
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