Cook Incorporated recalls Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5…
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 00827002312135103 affected lots16805456G31214008270023121421688645916874181168555131686750516815763
+95 more
1679666516802282167664371673416916695772G3121600827002312166168864601689129916912494168316761683635816836359168363601686453416864652168816551688250816912493168725591687826016824312168316751687418216855514168688891685973216858079168782611680627016804619168054541680439916815762168039201680392116802096168020971681436916814370168063331680462016831528168222891682229016782945167829461679573316796300167794371679573416800424168026321682431316764526167630241680073016802633168021331680073116821105168243141671111016717839167303261672015316736740167392911669365316690051166735691668024016704378G31220008270023122031688165716872241168271631685299916805455168044001680213216779438167303251673929216700199166900501666131216674400G312210082700231221016839296168799771681437116821104
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 detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1936-2026
- FDA 510(k) clearance · K173289The device's official FDA premarket clearance record
- FDA device classification · DQOOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cook IncorporatedSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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