Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic pr...
FDA Device Recall #Z-1902-2025 — Class I — May 15, 2025
Recall Summary
| Recall Number | Z-1902-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | May 15, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Incorporated |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 26986 units |
Product Description
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 for Recall
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
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(17)260201(10)15879285 (product), (01)10827002085975(17)260201(30)5(10)15879285 (box), Lot Number 15879285; 8) HNBR5.0-35-100-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; 9) HNBR5.0-35-125-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; 10) HNBR5.0-35-125-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; 11) HNBR5.0-35-125-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; 11) HNBR5.0-35-125-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; 11) HNBR5.0-35-125-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; 12) HNBR5.0-35-125-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; 13) HNBR5.0-35-40-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; 13) HNBR5.0-35-40-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; 13) HNBR5.0-35-40-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; 13) HNBR5.0-35-40-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; 13) HNBR5.0-35-40-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; 13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260327(10)15979535 (product), (01)10827002097510(17)260327(30)5(10)15979535 (box), Lot Number 15979535; 13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260328(10)15980166 (product), (01)10827002097510(17)260328(30)5(10)15980166 (box), Lot Number 15980166; 13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260405(10)15993143 (product), (01)10827002097510(17)260405(30)5(10)15993143 (box), Lot Number 15993143; 13) HNBR5.0-35-40-P-NS-KMP (RPN) G09751 (GPN), UDI: (01)00827002097513(17)260415(10)16008638 (product), (01)10827002097510(17)260415(30)5(10)16008638 (box), Lot Number 16008638; 14) HNBR5.0-35-40-P-NS-VANSCHIE3 (RPN) G31408 (GPN), UDI: (01)00827002314085(17)260318(10)15950809 (product), (01)10827002314082(17)260318(30)5(10)15950809 (box), Lot Number 15950809; 15) HNBR5.0-35-65-P-NS-C1 (RPN) G08441 (GPN), UDI: (01)00827002084414(17)260325(10)15972586 (product), (01)10827002084411(17)260325(30)5(10)15972586 (box), Lot Number 15972586; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260213(10)15895237 (product), (01)10827002084428(17)260213(30)5(10)15895237 (box), Lot Number 15895237; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260222(10)15912387 (product), (01)10827002084428(17)260222(30)5(10)15912387 (box), Lot Number 15912387; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260325(10)15972587 (product), (01)10827002084428(17)260325(30)5(10)15972587 (box), Lot Number 15972587; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260326(10)15976871 (product), (01)10827002084428(17)260326(30)5(10)15976871 (box), Lot Number 15976871; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260327(10)15979536 (product), (01)10827002084428(17)260327(30)5(10)15979536 (box), Lot Number 15979536; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260328(10)15980167 (product), (01)10827002084428(17)260328(30)5(10)15980167 (box), Lot Number 15980167; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260405(10)15993144 (product), (01)10827002084428(17)260405(30)5(10)15993144 (box), Lot Number 15993144; 16) HNBR5.0-35-65-P-NS-C2 (RPN) G08442 (GPN), UDI: (01)00827002084421(17)260411(10)16003545 (product), (01)10827002084428(17)260411(30)5(10)16003545 (box), Lot Number 16003545; 17) HNBR5.0-35-65-P-NS-C3 (RPN) G08443 (GPN), UDI: (01)00827002084438(17)260327(10)15978551 (product), (01)10827002084435(17)260327(30)5(10)15978551 (box), Lot Number 15978551; 18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260311(10)15940019 (product), (01)10827002114583(17)260311(30)5(10)15940019 (box), Lot Number 15940019; 18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260320(10)15957901 (product), (01)10827002114583(17)260320(30)5(10)15957901 (box), Lot Number 15957901; 18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260405(10)15993139 (product), (01)10827002114583(17)260405(30)5(10)15993139 (box), Lot Number 15993139; 18) HNBR5.0-35-65-P-NS-KMP (RPN) G11458 (GPN), UDI: (01)00827002114586(17)260411(10)16003556 (product), (01)10827002114583(17)260411(30)5(10)16003556 (box), Lot Number 16003556; 19) HNBR5.0-35-65-P-NS-RBT (RPN) G57015 (GPN), UDI: (01)00827002570153(17)260228(10)15921475 (product), (01)10827002570150(17)260228(30)5(10)15921475 (box), Lot Number 15921475; 19) HNBR5.0-35-65-P-NS-RBT (RPN) G57015 (GPN), UDI: (01)00827002570153(17)260312(10)15942327 (product), (01)10827002570150(17)260312(30)5(10)15942327 (box), Lot Number 15942327; 20) HNBR5.0-35-65-P-NS-RC1 (RPN) G08469 (GPN), UDI: (01)00827002084698(17)260325(10)15972578 (product), (01)10827002084695(17)260325(30)5(10)15972578 (box), Lot Number 15972578; 21) HNBR5.0-35-65-P-NS-RC2 (RPN) G08470 (GPN), UDI: (01)00827002084704(17)260325(10)15972577 (product), (01)10827002084701(17)260325(30)5(10)15972577 (box), Lot Number 15972577; 22) HNBR5.0-35-65-P-NS-RDC (RPN) G08596 (GPN), UDI: (01)00827002085961(17)260419(10)16017882 (product), (01)10827002085968(17)260419(30)5(10)16017882 (box), Lot Number 16017882; 23) HNBR5.0-35-65-P-NS-RIM (RPN) G08444 (GPN), UDI: (01)00827002084445(17)260412(10)16005235 (product), (01)10827002084442(17)260412(30)5(10)16005235 (box), Lot Number 16005235; 24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260306(10)15932470 (product), (01)10827002137957(17)260306(30)5(10)15932470 (box), Lot Number 15932470; 24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260306(10)15932471 (product), (01)10827002137957(17)260306(30)5(10)15932471 (box), Lot Number 15932471; 24) HNBR5.0-35-65-P-NS-VANSCHIE1 (RPN) G13795 (GPN), UDI: (01)00827002137950(17)260401(10)15984090 (product), (01)10827002137957(17)260401(30)5(10)15984090 (box), Lot Number 15984090; 25) HNBR5.0-35-65-P-NS-VANSCHIE2 (RPN) G13794 (GPN), UDI: (01)00827002137943(17)260405(10)15993140 (product), (01)10827002137940(17)260405(30)5(10)15993140 (box), Lot Number 15993140; 26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260315(10)15948952 (product), (01)10827002137926(17)260315(30)5(10)15948952 (box), Lot Number 15948952; 26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260319(10)15953576 (product), (01)10827002137926(17)260319(30)5(10)15953576 (box), Lot Number 15953576; 26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260320(10)15957904 (product), (01)10827002137926(17)260320(30)5(10)15957904 (box), Lot Number 15957904; 26) HNBR5.0-35-65-P-NS-VANSCHIE3 (RPN) G13792 (GPN), UDI: (01)00827002137929(17)260408(10)15995865 (product), (01)10827002137926(17)260408(30)5(10)15995865 (box), Lot Number 15995865; 27) HNBR5.0-35-65-P-NS-VANSCHIE4 (RPN) G13783 (GPN), UDI: (01)00827002137837(17)260205(10)15882844 (product), (01)10827002137834(17)260205(30)5(10)15882844 (box), Lot Number 15882844; 27) HNBR5.0-35-65-P-NS-VANSCHIE4 (RPN) G13783 (GPN), UDI: (01)00827002137837(17)260320(10)15957905 (product), (01)10827002137834(17)260320(30)5(10)15957905 (box), Lot Number 15957905; 28) HNBR5.0-35-65-P-NS-VANSCHIE5 (RPN) G13793 (GPN), UDI: (01)00827002137936(17)260216(10)15901238 (product), (01)10827002137933(17)260216(30)5(10)15901238 (box), Lot Number 15901238; 28) HNBR5.0-35-65-P-NS-VANSCHIE5 (RPN) G13793 (GPN), UDI: (01)00827002137936(17)260320(10)15957910 (product), (01)10827002137933(17)260320(30)5(10)15957910 (box), Lot Number 15957910; 29) HNBR5.0-35-80-P-NS-C2 (RPN) G11202 (GPN), UDI: (01)00827002112025(17)260315(10)15948953 (product), (01)10827002112022(17)260315(30)5(10)15948953 (box), Lot Number 15948953; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260228(10)15921476 (product), (01)10827002570174(17)260228(30)5(10)15921476 (box), Lot Number 15921476; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260228(10)15924172 (product), (01)10827002570174(17)260228(30)5(10)15924172 (box), Lot Number 15924172; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260319(10)15956478 (product), (01)10827002570174(17)260319(30)5(10)15956478 (box), Lot Number 15956478; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260322(10)15971078 (product), (01)10827002570174(17)260322(30)5(10)15971078 (box), Lot Number 15971078; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260328(10)15981406 (product), (01)10827002570174(17)260328(30)5(10)15981406 (box), Lot Number 15981406; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260328(10)15981407 (product), (01)10827002570174(17)260328(30)5(10)15981407 (box), Lot Number 15981407; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260403(10)15988580 (product), (01)10827002570174(17)260403(30)5(10)15988580 (box), Lot Number 15988580; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260403(10)15988581 (product), (01)10827002570174(17)260403(30)5(10)15988581 (box), Lot Number 15988581; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260408(10)15995788 (product), (01)10827002570174(17)260408(30)5(10)15995788 (box), Lot Number 15995788; 30) HNBR5.0-35-90-P-NS-RBT (RPN) G57017 (GPN), UDI: (01)00827002570177(17)260315(10)NS15948960 (product), (01)10827002570174(17)260315(30)5(10)NS15948960 (box), Lot Number NS15948960; 31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260315(10)15948954 (product), (01)10827002085814(17)260315(30)5(10)15948954 (box), Lot Number 15948954; 31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260403(10)15988266 (product), (01)10827002085814(17)260403(30)5(10)15988266 (box), Lot Number 15988266; 31) HNBR5.0-38-100-P-NS-DAV (RPN) G08581 (GPN), UDI: (01)00827002085817(17)260311(10)NS15940014 (product), (01)10827002085814(17)260311(30)5(10)NS15940014 (box), Lot Number NS15940014; 32) HNBR5.0-38-100-P-NS-H1 (RPN) G08419 (GPN), UDI: (01)00827002084193(17)260201(10)15879274 (product), (01)10827002084190(17)260201(30)5(10)15879274 (box), Lot Number 15879274; 33) HNBR5.0-38-100-P-NS-JB1 (RPN) G08583 (GPN), UDI: (01)00827002085831(17)260318(10)15950803 (product), (01)10827002085838(17)260318(30)5(10)15950803 (box), Lot Number 15950803; 34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260326(10)15975568 (product), (01)10827002114576(17)260326(30)5(10)15975568 (box), Lot Number 15975568; 34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260327(10)15979537 (product), (01)10827002114576(17)260327(30)5(10)15979537 (box), Lot Number 15979537; 34) HNBR5.0-38-100-P-NS-KMP (RPN) G11457 (GPN), UDI: (01)00827002114579(17)260415(10)16008467 (product), (01)10827002114576(17)260415(30)5(10)16008467 (box), Lot Number 16008467; 35) HNBR5.0-38-100-P-NS-MPB (RPN) G11206 (GPN), UDI: (01)00827002112063(17)260311(10)NS15940015 (product), (01)10827002112060(17)260311(30)5(10)NS15940015 (box), Lot Number NS15940015; 36) HNBR5.0-38-100-P-NS-SHETTY-050181 (RPN) G11475 (GPN), UDI: (01)00827002114753(17)260222(10)NS15912381 (product), (01)10827002114750(17)260222(30)5(10)NS15912381 (box), Lot Number NS15912381; 36) HNBR5.0-38-100-P-NS-SHETTY-050181 (RPN) G11475 (GPN), UDI: (01)00827002114753(17)260222(10)NS15912382 (product), (01)10827002114750(17)260222(30)5(10)NS15912382 (box), Lot Number NS15912382; 37) HNBR5.0-38-100-P-NS-SIM1 (RPN) G08584 (GPN), UDI: (01)00827002085848(17)260327(10)15978552 (product), (01)10827002085845(17)260327(30)5(10)15978552 (box), Lot Number 15978552; 38) HNBR5.0-38-100-P-NS-SIM2 (RPN) G08420 (GPN), UDI: (01)00827002084209(17)260403(10)15988259 (product), (01)10827002084206(17)260403(30)5(10)15988259 (box), Lot Number 15988259; 39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260220(10)15907355 (product), (01)10827002114842(17)260220(30)5(10)15907355 (box), Lot Number 15907355; 39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260307(10)15935929 (product), (01)10827002114842(17)260307(30)5(10)15935929 (box), Lot Number 15935929; 39) HNBR5.0-38-100-P-NS-VERT (RPN) G11484 (GPN), UDI: (01)00827002114845(17)260403(10)15988267 (product), (01)10827002114842(17)260403(30)5(10)15988267 (box), Lot Number 15988267; 40) HNBR5.0-38-100-P-NS-VS2 (RPN) G11487 (GPN), UDI: (01)00827002114876(17)260222(10)15912385 (product), (01)10827002114873(17)260222(30)5(10)15912385 (box), Lot Number 15912385; 41) HNBR5.0-38-125-P-NS-H1 (RPN) G11378 (GPN), UDI: (01)00827002113787(17)260408(10)NS15995783 (product), (01)10827002113784(17)260408(30)5(10)NS15995783 (box), Lot Number NS15995783; 42) HNBR5.0-38-125-P-NS-JB2 (RPN) G11883 (GPN), UDI: (01)00827002118836(17)260307(10)NS15937068 (product), (01)10827002118833(17)260307(30)5(10)NS15937068 (box), Lot Number NS15937068; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260308(10)15937663 (product), (01)10827002121703(17)260308(30)5(10)15937663 (box), Lot Number 15937663; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260311(10)15941117 (product), (01)10827002121703(17)260311(30)5(10)15941117 (box), Lot Number 15941117; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260325(10)15972579 (product), (01)10827002121703(17)260325(30)5(10)15972579 (box), Lot Number 15972579; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260404(10)15990981 (product), (01)10827002121703(17)260404(30)5(10)15990981 (box), Lot Number 15990981; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260408(10)15995862 (product), (01)10827002121703(17)260408(30)5(10)15995862 (box), Lot Number 15995862; 43) HNBR5.0-38-125-P-NS-VERT (RPN) G12170 (GPN), UDI: (01)00827002121706(17)260408(10)NS15995784 (product), (01)10827002121703(17)260408(30)5(10)NS15995784 (box), Lot Number NS15995784; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260307(10)15936458 (product), (01)10827002116426(17)260307(30)5(10)15936458 (box), Lot Number 15936458; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260311(10)15941118 (product), (01)10827002116426(17)260311(30)5(10)15941118 (box), Lot Number 15941118; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260404(10)15990977 (product), (01)10827002116426(17)260404(30)5(10)15990977 (box), Lot Number 15990977; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260404(10)15990984 (product), (01)10827002116426(17)260404(30)5(10)15990984 (box), Lot Number 15990984; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260405(10)15993149 (product), (01)10827002116426(17)260405(30)5(10)15993149 (box), Lot Number 15993149; 44) HNBR5.0-38-125-P-NS-VTK (RPN) G11642 (GPN), UDI: (01)00827002116429(17)260408(10)NS15995785 (product), (01)10827002116426(17)260408(30)5(10)NS15995785 (box), Lot Number NS15995785; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260216(10)15902079 (product), (01)10827002095486(17)260216(30)5(10)15902079 (box), Lot Number 15902079; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260328(10)15980884 (product), (01)10827002095486(17)260328(30)5(10)15980884 (box), Lot Number 15980884; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983218 (product), (01)10827002095486(17)260329(30)5(10)15983218 (box), Lot Number 15983218; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983219 (product), (01)10827002095486(17)260329(30)5(10)15983219 (box), Lot Number 15983219; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260329(10)15983220 (product), (01)10827002095486(17)260329(30)5(10)15983220 (box), Lot Number 15983220; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991907 (product), (01)10827002095486(17)260404(30)5(10)15991907 (box), Lot Number 15991907; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991909 (product), (01)10827002095486(17)260404(30)5(10)15991909 (box), Lot Number 15991909; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991910 (product), (01)10827002095486(17)260404(30)5(10)15991910 (box), Lot Number 15991910; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260404(10)15991911 (product), (01)10827002095486(17)260404(30)5(10)15991911 (box), Lot Number 15991911; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006219 (product), (01)10827002095486(17)260412(30)5(10)16006219 (box), Lot Number 16006219; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006227 (product), (01)10827002095486(17)260412(30)5(10)16006227 (box), Lot Number 16006227; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260412(10)16006228 (product), (01)10827002095486(17)260412(30)5(10)16006228 (box), Lot Number 16006228; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260419(10)16018901 (product), (01)10827002095486(17)260419(30)5(10)16018901 (box), Lot Number 16018901; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260424(10)16027942 (product), (01)10827002095486(17)260424(30)5(10)16027942 (box), Lot Number 16027942; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028949 (product), (01)10827002095486(17)260425(30)5(10)16028949 (box), Lot Number 16028949; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028950 (product), (01)10827002095486(17)260425(30)5(10)16028950 (box), Lot Number 16028950; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260425(10)16028952 (product), (01)10827002095486(17)260425(30)5(10)16028952 (box), Lot Number 16028952; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260426(10)16030430 (product), (01)10827002095486(17)260426(30)5(10)16030430 (box), Lot Number 16030430; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260502(10)16039989 (product), (01)10827002095486(17)260502(30)5(10)16039989 (box), Lot Number 16039989; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260502(10)16039990 (product), (01)10827002095486(17)260502(30)5(10)16039990 (box), Lot Number 16039990; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041716 (product), (01)10827002095486(17)260503(30)5(10)16041716 (box), Lot Number 16041716; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041717 (product), (01)10827002095486(17)260503(30)5(10)16041717 (box), Lot Number 16041717; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260503(10)16041718 (product), (01)10827002095486(17)260503(30)5(10)16041718 (box), Lot Number 16041718; 45) HNBR5.0-38-40-P-NS-KMP (RPN) G09548 (GPN), UDI: (01)00827002095489(17)260506(10)16045117 (product), (01)10827002095486(17)260506(30)5(10)16045117 (box), Lot Number 16045117; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260213(10)15895235 (product), (01)10827002084473(17)260213(30)5(10)15895235 (box), Lot Number 15895235; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260305(10)15930790 (product), (01)10827002084473(17)260305(30)5(10)15930790 (box), Lot Number 15930790; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260311(10)15940018 (product), (01)10827002084473(17)260311(30)5(10)15940018 (box), Lot Number 15940018; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260314(10)15947372 (product), (01)10827002084473(17)260314(30)5(10)15947372 (box), Lot Number 15947372; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260318(10)15952568 (product), (01)10827002084473(17)260318(30)5(10)15952568 (box), Lot Number 15952568; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260325(10)15972580 (product), (01)10827002084473(17)260325(30)5(10)15972580 (box), Lot Number 15972580; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260326(10)15975571 (product), (01)10827002084473(17)260326(30)5(10)15975571 (box), Lot Number 15975571; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260328(10)15980163 (product), (01)10827002084473(17)260328(30)5(10)15980163 (box), Lot Number 15980163; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260328(10)15980165 (product), (01)10827002084473(17)260328(30)5(10)15980165 (box), Lot Number 15980165; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260408(10)15995863 (product), (01)10827002084473(17)260408(30)5(10)15995863 (box), Lot Number 15995863; 46) HNBR5.0-38-65-P-NS-C2 (RPN) G08447 (GPN), UDI: (01)00827002084476(17)260416(10)16010287 (product), (01)10827002084473(17)260416(30)5(10)16010287 (box), Lot Number 16010287; 47) HNBR5.0-38-65-P-NS-H1 (RPN) G11395 (GPN), UDI: (01)00827002113954(17)260311(10)NS15940007 (product), (01)10827002113951(17)260311(30)5(10)NS15940007 (box), Lot Number NS15940007; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260220(10)15908438 (product), (01)10827002094694(17)260220(30)5(10)15908438 (box), Lot Number 15908438; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260318(10)15952413 (product), (01)10827002094694(17)260318(30)5(10)15952413 (box), Lot Number 15952413; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260321(10)15970067 (product), (01)10827002094694(17)260321(30)5(10)15970067 (box), Lot Number 15970067; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260321(10)15970068 (product), (01)10827002094694(17)260321(30)5(10)15970068 (box), Lot Number 15970068; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260326(10)15977848 (product), (01)10827002094694(17)260326(30)5(10)15977848 (box), Lot Number 15977848; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260327(10)15979424 (product), (01)10827002094694(17)260327(30)5(10)15979424 (box), Lot Number 15979424; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260328(10)15980885 (product), (01)10827002094694(17)260328(30)5(10)15980885 (box), Lot Number 15980885; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260328(10)15980895 (product), (01)10827002094694(17)260328(30)5(10)15980895 (box), Lot Number 15980895; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260329(10)15983223 (product), (01)10827002094694(17)260329(30)5(10)15983223 (box), Lot Number 15983223; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260404(10)15991916 (product), (01)10827002094694(17)260404(30)5(10)15991916 (box), Lot Number 15991916; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260405(10)15993769 (product), (01)10827002094694(17)260405(30)5(10)15993769 (box), Lot Number 15993769; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260410(10)16000849 (product), (01)10827002094694(17)260410(30)5(10)16000849 (box), Lot Number 16000849; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006220 (product), (01)10827002094694(17)260412(30)5(10)16006220 (box), Lot Number 16006220; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006231 (product), (01)10827002094694(17)260412(30)5(10)16006231 (box), Lot Number 16006231; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260412(10)16006232 (product), (01)10827002094694(17)260412(30)5(10)16006232 (box), Lot Number 16006232; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012518 (product), (01)10827002094694(17)260417(30)5(10)16012518 (box), Lot Number 16012518; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012520 (product), (01)10827002094694(17)260417(30)5(10)16012520 (box), Lot Number 16012520; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012523 (product), (01)10827002094694(17)260417(30)5(10)16012523 (box), Lot Number 16012523; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260417(10)16012526 (product), (01)10827002094694(17)260417(30)5(10)16012526 (box), Lot Number 16012526; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260418(10)16014926 (product), (01)10827002094694(17)260418(30)5(10)16014926 (box), Lot Number 16014926; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260502(10)16039993 (product), (01)10827002094694(17)260502(30)5(10)16039993 (box), Lot Number 16039993; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260509(10)16052595 (product), (01)10827002094694(17)260509(30)5(10)16052595 (box), Lot Number 16052595; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260510(10)16054256 (product), (01)10827002094694(17)260510(30)5(10)16054256 (box), Lot Number 16054256; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260510(10)16054257 (product), (01)10827002094694(17)260510(30)5(10)16054257 (box), Lot Number 16054257; 48) HNBR5.0-38-65-P-NS-KMP (RPN) G09469 (GPN), UDI: (01)00827002094697(17)260515(10)16061281 (product), (01)10827002094694(17)260515(30)5(10)16061281 (box), Lot Number 16061281; 49) HNBR5.0-38-65-P-NS-LEV2 (RPN) G11207 (GPN), UDI: (01)00827002112070(17)260304(10)NS15928703 (product), (01)10827002112077(17)260304(30)5(10)NS15928703 (box), Lot Number NS15928703; 50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260318(10)15950806 (product), (01)10827002111957(17)260318(30)5(10)15950806 (box), Lot Number 15950806; 50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260328(10)15980164 (product), (01)10827002111957(17)260328(30)5(10)15980164 (box), Lot Number 15980164; 50) HNBR5.0-38-65-P-NS-MPA (RPN) G11195 (GPN), UDI: (01)00827002111950(17)260409(10)15997227 (product), (01)10827002111957(17)260409(30)5(10)15997227 (box), Lot Number 15997227; 51) HNBR5.0-38-65-P-NS-MPB (RPN) G11470 (GPN), UDI: (01)00827002114708(17)260311(10)NS15940008 (product), (01)10827002114705(17)260311(30)5(10)NS15940008 (box), Lot Number NS15940008; 52) HNBR5.0-38-65-P-NS-RDC (RPN) G08578 (GPN), UDI: (01)00827002085787(17)260307(10)15936460 (product), (01)10827002085784(17)260307(30)5(10)15936460 (box), Lot Number 15936460; 52) HNBR5.0-38-65-P-NS-RDC (RPN) G08578 (GPN), UDI: (01)00827002085787(17)260318(10)15952569 (product), (01)10827002085784(17)260318(30)5(10)15952569 (box), Lot Number 15952569; 53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260220(10)15907353 (product), (01)10827002100821(17)260220(30)5(10)15907353 (box), Lot Number 15907353; 53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260304(10)15928714 (product), (01)10827002100821(17)260304(30)5(10)15928714 (box), Lot Number 15928714; 53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260314(10)15947373 (product), (01)10827002100821(17)260314(30)5(10)15947373 (box), Lot Number 15947373; 53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260405(10)15993141 (product), (01)10827002100821(17)260405(30)5(10)15993141 (box), Lot Number 15993141; 53) HNBR5.0-38-65-P-NS-RIM (RPN) G10082 (GPN), UDI: (01)00827002100824(17)260411(10)16003553 (product), (01)10827002100821(17)260411(30)5(10)16003553 (box), Lot Number 16003553; 54) HNBR5.0-38-65-P-NS-SHK1.0 (RPN) G11476 (GPN), UDI: (01)00827002114760(17)260319(10)15953573 (product), (01)10827002114767(17)260319(30)5(10)15953573 (box), Lot Number 15953573; 55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260408(10)15995864 (product), (01)10827002086774(17)260408(30)5(10)15995864 (box), Lot Number 15995864; 55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260409(10)15997228 (product), (01)10827002086774(17)260409(30)5(10)15997228 (box), Lot Number 15997228; 55) HNBR5.0-38-65-P-NS-SIM1 (RPN) G08677 (GPN), UDI: (01)00827002086777(17)260416(10)16010286 (product), (01)10827002086774(17)260416(30)5(10)16010286 (box), Lot Number 16010286; 56) HNBR5.0-38-65-P-NS-SIM2 (RPN) G08625 (GPN), UDI: (01)00827002086258(17)260216(10)15901240 (product), (01)10827002086255(17)260216(30)5(10)15901240 (box), Lot Number 15901240; 56) HNBR5.0-38-65-P-NS-SIM2 (RPN) G08625 (GPN), UDI: (01)00827002086258(17)260307(10)15936461 (product), (01)10827002086255(17)260307(30)5(10)15936461 (box), Lot Number 15936461; 57) HNBR5.0-38-65-P-NS-SIM3 (RPN) G08849 (GPN), UDI: (01)00827002088498(17)260201(10)NS15877682 (product), (01)10827002088495(17)26
Other Recalls from Cook Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1936-2026 | Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN ... | Apr 2, 2026 |
| Z-1935-2026 | Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-... | Apr 2, 2026 |
| Z-1934-2026 | Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-1... | Apr 2, 2026 |
| Z-1780-2026 | Class II | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous ... | Mar 5, 2026 |
| Z-1785-2026 | Class II | Melker Universal Cuffed Emergency Cricothyrotom... | Mar 5, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.