FDA Device recall Z-1902-2025
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures
- FDA Device
- Class I
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class I recall of Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures by Cook, citing cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1902-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
Reason
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Identifiers
| code_info | 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087…1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260202(10)15881668 (product), (01)10827002087962(17)260202(30)5(10)15881668 (box), Lot Number 15881668; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260219(10)15903001 (product), (01)10827002087962(17)260219(30)5(10)15903001 (box), Lot Number 15903001; 1) HNBR5.0-35-100-P-NS-C2 (RPN) G08796 (GPN), UDI: (01)00827002087965(17)260306(10)NS15932463 (product), (01)10827002087962(17)260306(30)5(10)NS15932463 (box), Lot Number NS15932463; 2) HNBR5.0-35-100-P-NS-DAV (RPN) G08699 (GPN), UDI: (01)00827002086999(17)260411(10)16003554 (product), (01)10827002086996(17)260411(30)5(10)16003554 (box), Lot Number 16003554; 3) HNBR5.0-35-100-P-NS-H1 (RPN) G08421 (GPN), UDI: (01)00827002084216(17)260314(10)15948423 (product), (01)10827002084213(17)260314(30)5(10)15948423 (box), Lot Number 15948423; 4) HNBR5.0-35-100-P-NS-JB2 (RPN) G08809 (GPN), UDI: (01)00827002088092(17)260319(10)15953578 (pro |
|---|
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-1902-2025%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.