Cook Incorporated: 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).

Recall number

Z-1936-2026

Recalling firm

Cook Incorporated

Product

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).

Status

Open, Classified

Initiated

2026-04-02

Posted

2026-05-01

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

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.

Quantity

4,245

Distribution

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

Lot, serial or model codes

G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots 16886459 16874181 16855513 16867505 16815763 16796665 16802282 16766437 16734169 16695772 G31216 UDI-DI 00827002312166 Lots 16886460 16891299 16912494 16831676 16836358 16836359 16836360 16864534 16864652 16881655 16882508 16912493 16872559 16878260 16824312 16831675 16874182 16855514 16868889 16859732 16858079 16878261 16806270 16804619 16805454 16804399 16815762 16803920 16803921 16802096 16802097 16814369 16814370 16806333 16804620 16831528 16822289 16822290 16782945 16782946 16795733 16796300 16779437 16795734 16800424 16802632 16824313 16764526 16763024 16800730 16802633 16802133 16800731 16821105 16824314 16711110 16717839 16730326 16720153 16736740 16739291 16693653 16690051 16673569 16680240 16704378 G31220 UDI-DI 00827002312203 Lots 16881657 16872241 16827163 16852999 16805455 16804400 16802132 16779438 16730325 16739292 16700199 16690050 16661312 16674400 G31221 UDI-DI 00827002312210 Lots 16839296 16879977 16814371 16821104

510(k) numbers

["K173289"]

PMA numbers

not on file

Product code

DQO

Firm FEI

1820334

Firm city

Bloomington

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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