Reported May 13, 2026 · Ongoing
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…
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 Centimeter Sizing Catheter RPN/GPNSizing 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).
NR5.0-35-70-P-10S-0-CSC-20G31213NR5.0-35-100-P-10S-0-CSC-20G31214NR5.0-35-100-P-10S-PIG-CSC-20G31216NR5.0-35-70-P-10S-VCF-CSC-20G31220NR5.0-35-100-P-10S-VCF-CSC-20G31221
- Lot codes and dates
- G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 LotsUDI-DI 00827002312166 Lots
16886459168741811685551316867505168157631679666516802282167664371673416916695772G31216
UDI-DI 00827002312203 Lots67 of 67 codes
168864601689129916912494168316761683635816836359168363601686453416864652168816551688250816912493168725591687826016824312168316751687418216855514168688891685973216858079168782611680627016804619168054541680439916815762168039201680392116802096168020971681436916814370168063331680462016831528168222891682229016782945167829461679573316796300167794371679573416800424168026321682431316764526167630241680073016802633168021331680073116821105168243141671111016717839167303261672015316736740
UDI-DI 00827002312210 Lots 16839296 16879977 16814371 168211041688165716872241168271631685299916805455168044001680213216779438167303251673929216700199166900501666131216674400G31221
- G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots
- Amount recalled
- 4,245
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
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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