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Micromyst applicator and extended tip applicators

Official notice

11 Jun 2025

Last checked

11 Jun 2025

Medium riskHealth Canada

An official Health Canada notice concerns Micromyst applicator and extended tip applicators. The decision to conduct a recall of the MicroMyst applicator and extended tip applicators was based on internal investigation that demonstrated an incomplete bioburden assessment and an incomplete sterilization location transfer documentation to ensure the effectiveness of the sterilization process. The investigation also identified that the extended tip applicators, exclusively, could potentially contain out-of-specification levels of endotoxin. Recall start date: June 2, 2025 Published 2025-06-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77582

Official notice

2025-06-11

The hazard

The decision to conduct a recall of the MicroMyst applicator and extended tip applicators was based on internal investigation that demonstrated an incomplete bioburden assessment and an incomplete sterilization location transfer documentation to ensure the effectiveness of the sterilization process. The investigation also identified that the extended tip applicators, exclusively, could potentially contain out-of-specification levels of endotoxin. Recall start date: June 2, 2025

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.

Recall Numbers

77582

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Affected products

Product 1

Affected products - Extended Tip Applicator - Single Use Applicator 15 Cm, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 205115

Product 2

Affected products - MicroMyst Applicator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 205000DS

Product 3

Affected products - Extended Tip Applicator - Single Use Applicator 8 Cm, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 205108

Risk / hazard

The decision to conduct a recall of the MicroMyst applicator and extended tip applicators was based on internal investigation that demonstrated an incomplete bioburden assessment and an incomplete sterilization location transfer documentation to ensure the effectiveness of the sterilization process. The investigation also identified that the extended tip applicators, exclusively, could potentially contain out-of-specification levels of endotoxin. Recall start date: June 2, 2025

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: Integra Lifesciences Also Dba Integra Neurosciences, Micromyst Applicator And Extended Tip Applicators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77582

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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