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RecallWatchMedical Device Safety
Class IOngoingZ-1936-2026

Cook Incorporated recalls Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5…

Cook IncorporatedBloomington, IN, United StatesReported May 13, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF)
    UDI-DI 00827002312135
    103 affected lots
    16805456G31214008270023121421688645916874181168555131686750516815763
    +95 more1679666516802282167664371673416916695772G3121600827002312166168864601689129916912494168316761683635816836359168363601686453416864652168816551688250816912493168725591687826016824312168316751687418216855514168688891685973216858079168782611680627016804619168054541680439916815762168039201680392116802096168020971681436916814370168063331680462016831528168222891682229016782945167829461679573316796300167794371679573416800424168026321682431316764526167630241680073016802633168021331680073116821105168243141671111016717839167303261672015316736740167392911669365316690051166735691668024016704378G31220008270023122031688165716872241168271631685299916805455168044001680213216779438167303251673929216700199166900501666131216674400G312210082700231221016839296168799771681437116821104

What the firm is doing

On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.

DistributionShow details

US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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