FDA Medical devices recall ·
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1902-2025
- Date
- (initiated May 15, 2025)
- Company / brand
- Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 26986 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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).
Why was it recalled?
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 (product), (01)10827002088099(17)260319(30)5(10)15953578 (box), Lot Number 15953578; 5) HNBR5.0-35-100-P-NS-SIM1 (RPN) G08471 (GPN), UDI: (01)00827002084711(17)260401(10)15984088 (product), (01)10827002084718(17)260401(30)5(10)15984088 (box), Lot Number 15984088; 6) HNBR5.0-35-100-P-NS-SIM2 (RPN) G08422 (GPN), UDI: (01)00827002084223(17)260220(10)15907359 (product), (01)10827002084220(17)260220(30)5(10)15907359 (box), Lot Number 15907359; 7) HNBR5.0-35-100-P-NS-SIM3 (RPN) G08597 (GPN), UDI: (01)00827002085978(
Distribution
Worldwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1902-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.