Reported Jun 25, 2025 · Ongoing
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters…
Cook Incorporated
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- 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).
- Lot codes and dates
179 of 179 products
Products covered by this recall # Barcodes Product as published 1 0082700208796510827002087962HNBR5.0-35-100-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 2 0082700208796510827002087962HNBR5.0-35-100-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 3 0082700208699910827002086996HNBR5.0-35-100-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 4 0082700208421610827002084213HNBR5.0-35-100-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 5 0082700208809210827002088099HNBR5.0-35-100-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 6 0082700208471110827002084718HNBR5.0-35-100-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 7 0082700208422310827002084220HNBR5.0-35-100-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 8 0082700208597810827002085975HNBR5.0-35-100-P-NS-SIM3 (RPN) G08597 (GPN), UDI: (01)00827002085978(17)260201(10)15879285 (product), (01)10827002085975(17)260201(30)5(10)15879285 (box), Lot Number 15879285 9 0082700211483810827002114835HNBR5.0-35-100-P-NS-VERT (RPN) G11483 (GPN), UDI: (01)00827002114838(17)260222(10)NS15912380 (product), (01)10827002114835(17)260222(30)5(10)NS15912380 (box), Lot Number NS15912380 10 0082700212899610827002128993HNBR5.0-35-125-P-NS-C2 (RPN) G12899 (GPN), UDI: (01)00827002128996(17)260407(10)NS15995667 (product), (01)10827002128993(17)260407(30)5(10)NS15995667 (box), Lot Number NS15995667 11 0082700235733410827002357331HNBR5.0-35-125-P-NS-VANSCHIE1 (RPN) G35733 (GPN), UDI: (01)00827002357334(17)260325(10)15972583 (product), (01)10827002357331(17)260325(30)5(10)15972583 (box), Lot Number 15972583 12 0082700235736510827002357362HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260308(10)15937655 (product), (01)10827002357362(17)260308(30)5(10)15937655 (box), Lot Number 15937655 13 0082700235736510827002357362HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260325(10)15972584 (product), (01)10827002357362(17)260325(30)5(10)15972584 (box), Lot Number 15972584 14 0082700235736510827002357362HNBR5.0-35-125-P-NS-VANSCHIE4 (RPN) G35736 (GPN), UDI: (01)00827002357365(17)260408(10)15995781 (product), (01)10827002357362(17)260408(30)5(10)15995781 (box), Lot Number 15995781 15 0082700235737210827002357379HNBR5.0-35-125-P-NS-VANSCHIE5 (RPN) G35737 (GPN), UDI: (01)00827002357372(17)260408(10)15995782 (product), (01)10827002357379(17)260408(30)5(10)15995782 (box), Lot Number 15995782 16 0082700209751310827002097510HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260202(10)15881670 (product), (01)10827002097510(17)260202(30)5(10)15881670 (box), Lot Number 15881670 17 0082700209751310827002097510HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260213(10)15895236 (product), (01)10827002097510(17)260213(30)5(10)15895236 (box), Lot Number 15895236 18 0082700209751310827002097510HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260314(10)15948424 (product), (01)10827002097510(17)260314(30)5(10)15948424 (box), Lot Number 15948424 19 0082700209751310827002097510HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260320(10)15957900 (product), (01)10827002097510(17)260320(30)5(10)15957900 (box), Lot Number 15957900 20 0082700209751310827002097510HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260326(10)15976870 (product), (01)10827002097510(17)260326(30)5(10)15976870 (box), Lot Number 15976870 - Amount recalled
- 26986 units
Why it was recalled
Stop using this product now
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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