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Medline Neuro Sponges Recall - Elevated Endotoxin Risk

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Summary

Health Canada issued a Type II recall for Medline Neuro Sponges (Gauze Sponges, X-Ray Detectable) due to potential out-of-specification endotoxin levels. Affected products include all lots of eight model numbers (NEUROSPNG05, 02, 13, 06, 07, 14, 09, 11). Elevated endotoxin levels may require medical or surgical intervention, though the likelihood of adverse health consequences is considered remote. Healthcare facilities must destroy recalled products immediately.

What changed

Health Canada issued a Type II medical device recall for Medline Neuro Sponges due to potential out-of-specification endotoxin levels. All lots of eight model numbers are affected. The recall was initiated by Medline Industries, LP (Northfield, Illinois) and published on March 30, 2026.

Healthcare facilities and providers using these sponges must immediately identify affected products, cease use, and destroy them. While the likelihood of adverse health consequences is considered remote, elevated endotoxin levels could potentially require medical or surgical intervention if patient exposure occurred. Facilities should review their inventory management systems and procurement records to ensure complete removal of affected lots.

What to do next

  1. Destroy all recalled Medline Neuro Sponges (all lots, models NEUROSPNG05, 02, 13, 06, 07, 14, 09, 11)
  2. Cease use of affected products and quarantine remaining inventory
  3. Report any adverse health consequences potentially related to endotoxin exposure to Health Canada

Penalties

Health product recall - non-compliance may result in regulatory enforcement action

Archived snapshot

Apr 10, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

Medline Neuro Sponges

Brand(s)

Medline Industries, Lp

Last updated

2026-04-09

Summary

Product Medline Neuro Sponges Issue Medical devices - Sterility What to do Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalogue number
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG05
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG02
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG13
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG06
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG07
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG14
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG09
Gauze Sponges, X-Ray Detectable All lots. NEUROSPNG11

Issue

Specific item(s) and lot(s) of Medline neuro sponges are recalled due to a potential out-of-specification for endotoxin. Elevated endotoxin levels may present potential health risks that could require medical or surgical intervention. The likelihood of adverse health consequences is considered remote. Customers are advised to destroy the recalled products.

Additional information

Details

Original published date:

2026-04-09

Alert / recall type Health product recall Category Health products - Medical devices - General and plastic surgery Companies Medline Industries, LP

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by Health Canada Audience General public Healthcare Industry Recall class Type II Recall date

2026-03-30

Identification number RA-81871

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Last updated

Classification

Agency
HC
Filed
March 30th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81871

Who this affects

Applies to
Healthcare providers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Product destruction Adverse event reporting
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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