The Recall Desk
HighFDA (Devices)·Z-1902-2025·Announced 2025-06-25

[pending] Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic proce

Pending LLM rewrite. Source: FDA_DEVICE Z-1902-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

The recalled product

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 coati
Manufacturer
Cook Incorporated
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • UDI: (01)00827002087965(17)260219(10)15903001 (product)
  • (01)10827002087962(17)260219(30)5(10)15903001 (box)
  • Lot Number 15903001
  • 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)

Distribution

Distribution scope not specified by the agency.

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