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Cook medical beacon® tip centimeter sizing catheter

Official notice

28 Apr 2026

MediumHealth Canada

An official Health Canada notice concerns Cook medical beacon® tip centimeter sizing catheter. Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples had underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check. This issue has been isolated to specific supplier lots of these marker bands. Published 2026-04-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81989

Official notice

2026-04-28

The hazard

Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples had underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check. This issue has been isolated to specific supplier lots of these marker bands.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

RA RA-81989

Recall Numbers

81989

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Affected products

Product 1

Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - N5.0-35-100-P-10S-0-CSC-20

Product 2

Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - NR5.0-35-70-P-10S-0-CSC-20

Product 3

Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - N5.0-35-100-P-10S-PIG-CSC-20

Risk / hazard

Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples had underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check. This issue has been isolated to specific supplier lots of these marker bands.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Cook.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81989

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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