FDA Device recall Z-1426-2025
Brand Name: Banner University Med Ctr
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Brand Name: Banner University Med Ctr by American Contract Systems, citing sterility assurance with procedure trays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1426-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | AZ |
Product
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
Reason
Sterility assurance with procedure trays
Identifiers
| code_info | Lot Code: UDI-DI: 00191072182845; Lot: 9219618; Exp: 01/21/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.