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Neurological sponges

Official notice

21 May 2026

MediumHealth Canada

An official Health Canada notice concerns Neurological sponges. During an internal review, Medicom has identified the potential for unexpected variability of endotoxin levels on the products. While the products have been demonstrated to consistently meet the endotoxin specification for blood contacting or implantable products, variability has been observed indicating that products in the market potentially may not consistently meet the more stringent endotoxin specification for devices that contact the cerebrospinal fluid. Published 2026-05-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82100

Official notice

2026-05-21

The hazard

During an internal review, Medicom has identified the potential for unexpected variability of endotoxin levels on the products. While the products have been demonstrated to consistently meet the endotoxin specification for blood contacting or implantable products, variability has been observed indicating that products in the market potentially may not consistently meet the more stringent endotoxin specification for devices that contact the cerebrospinal fluid.

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.

Skus

55992C, 55994C, 55996C, 55995C, 55997C, 85995C, 85998C, 55998C, 55993C

Other

RA RA-82100

Model Numbers

55992C, 55994C, 55996C, 55995C, 55997C, 85995C, 85998C, 55998C, 55993C

Recall Numbers

82100

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55992C

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55994C

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55996C

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55995C

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55997C

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 85995C

Product 7

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 85998C

Product 8

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55998C

Product 9

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 55993C

Risk / hazard

During an internal review, Medicom has identified the potential for unexpected variability of endotoxin levels on the products. While the products have been demonstrated to consistently meet the endotoxin specification for blood contacting or implantable products, variability has been observed indicating that products in the market potentially may not consistently meet the more stringent endotoxin specification for devices that contact the cerebrospinal fluid.

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 · Quebec

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: AMD Medicom.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82100

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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