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Medline Neuro Sponges Recalled Over Endotoxin Concern

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Summary

Health Canada has issued a Type II medical device recall for Medline Neuro Sponges distributed across multiple surgical procedure kit and tray product lines due to a potential out-of-specification result for endotoxin. Elevated endotoxin levels may present potential health risks requiring medical or surgical intervention. All lots of affected products are included in the recall. Customers are advised to discard the recalled neuro sponge component prior to using the kit, as the likelihood of adverse health consequences is considered remote.

“Medline kits containing neuro sponges are being recalled due to a potential out-of-specification for endotoxin for the neuro sponges.”

Published by Health Canada on recalls-rappels.canada.ca . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

Health Canada operates a single recalls and safety alerts portal covering food, drugs, medical devices, consumer products, vehicles, and cosmetics. Roughly 100 alerts a month, with each entry tagged by hazard type, affected lots, distributor, and recommended consumer action. The portal is bilingual and aligns closely with FDA recalls in scope, so a Health Canada alert often signals a US recall is coming or has just landed. Watch this if you sell into Canada, run cross-border product compliance, or trade pharma equities exposed to recall events. Recent examples: Stryker Variax 2 locking screws pulled non-sterile, a Baxter head positioning adapter Type I recall, an Alecensaro hypertriglyceridemia and pancreatitis safety signal.

What changed

Health Canada classified this recall as Type II, meaning it addresses a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse consequences is remote. Medline Industries, LP is recalling neuro sponges that may contain elevated endotoxin levels across all lots of numerous surgical kit and tray product lines.

Healthcare providers using any of the identified Neuro Packs, ENT Trays, General Surgical Trays, Custom Orthopaedic, Oral/Dental, General Surgery, Cardiovascular, Urology, and Neurosurgery Custom Procedure Kits should verify whether their inventory contains the affected model and catalogue numbers. Where identified, the recalled neuro sponge component should be discarded prior to kit use. Healthcare facilities should also consider whether historical use of these products warrants patient follow-up given the remote but non-zero risk of adverse events.

Archived snapshot

Apr 24, 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

2026-04-22

Summary

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

Audience Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Neuro Packs All lots. CDS984000D
Neuro Packs All lots. DYNJ37190C
Neuro Packs All lots. DYNJ41856B
Neuro Packs All lots. DYNJ41856C
Neuro Packs All lots. DYNJ41857C
Neuro Packs All lots. DYNJ41857D
Neuro Packs All lots. DYNJ41858B
Neuro Packs All lots. DYNJ41858C
Neuro Packs All lots. DYNJ41859B
Neuro Packs All lots. DYNJ41859C
Neuro Packs All lots. DYNJ47568B
Neuro Packs All lots. DYNJ47575B
Neuro Packs All lots. DYNJ47575C
Neuro Packs All lots. DYNJ47575D
Neuro Packs All lots. DYNJ48508B
Neuro Packs All lots. DYNJ52381
Neuro Packs All lots. DYNJ52812A
Neuro Packs All lots. DYNJ65730A
Neuro Packs All lots. DYNJT3690
Neuro Packs All lots. DYNJT3694
Neuro Packs All lots. DYNJ39996F
Neuro Packs All lots. DYNJ39997F
Neuro Packs All lots. DYNJ41832C
Neuro Packs All lots. DYNJ46769B
Neuro Packs All lots. DYNJ46769C
Neuro Packs All lots. DYNJ39989G
ENT Trays All lots. DYNJ41676A
ENT Trays All lots. DYNJ41676B
ENT Trays All lots. DYNJ41922C
ENT Trays All lots. DYNJ41922D
ENT Trays All lots. DYNJ41923D
ENT Trays All lots. DYNJ49788B
ENT Trays All lots. DYNJ56847A
ENT Trays All lots. DYNJ56847B
ENT Trays All lots. DYNJ62803
ENT Trays All lots. DYNJ69558
ENT Trays All lots. DYNJ69558A
ENT Trays All lots. DYNJ69829
ENT Trays All lots. DYNJ82667
ENT Trays All lots. DYNJ84975
ENT Trays All lots. DYNJ87705
ENT Trays All lots. DYNJ87708
ENT Trays All lots. DYNJ903834B
ENT Trays All lots. DYNJ905543G
ENT Trays All lots. DYNJT3183
General Surgical Tray All lots. DYNJ59740A
General Surgical Tray All lots. DYNJ908680
General Surgical Tray All lots. DYNJ908680A
General Surgical Tray All lots. DYNJ908680B
General Surgical Tray All lots. DYNJ908680C
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41666A
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41666B
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41787G
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41787I
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41787J
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41831C
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ41833C
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJ46759F
Custom Orthopaedic Procedure Kit/Tray All lots. DYNJT3691A
Custom Oral\Dental Procedure Kit\Tray All lots. DYNJ41862C
Custom General Surgery Procedure Kit/Tray All lots. DYNJ42670A
Custom Cardiovascular Procedure Kit/Tray All lots. DYNJ88249
Custom Urology Procedure Kit/Tray All lots. DYNJT4030
Neurosurgery Custom Procedure Packs All lots. DYNJ37190D
Neurosurgery Custom Procedure Packs All lots. DYNJ37190F
Neurosurgery Custom Procedure Packs All lots. DYNJ40040C
Neurosurgery Custom Procedure Packs All lots. DYNJ40042C
Neurosurgery Custom Procedure Packs All lots. DYNJ41831D
Neurosurgery Custom Procedure Packs All lots. DYNJ41831F
Neurosurgery Custom Procedure Packs All lots. DYNJ41832D
Neurosurgery Custom Procedure Packs All lots. DYNJ41832F
Neurosurgery Custom Procedure Packs All lots. DYNJ49548A
Neurosurgery Custom Procedure Packs All lots. DYNJ87603
Neurosurgery Custom Procedure Packs All lots. DYNJ87715
Neurosurgery Custom Procedure Packs All lots. DYNJ903841D
Neurosurgery Custom Procedure Packs All lots. DYNJS1002
General Surgery Custom Procedure Packs All lots. DYNJ46781B
Composite Neck Dissec SHSC-LF All lots. DYNJ46776D

Issue

Medline kits containing neuro sponges are being recalled due to a potential out-of-specification for endotoxin for the neuro sponges. Elevated endotoxin levels may present potential health risks requiring medical or surgical intervention. The likelihood of adverse health consequences is considered remote. However, customers should discard the recalled component prior to using the kit.

Additional information

Details

Original published date:

2026-04-23

Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Health products - Medical devices - Ear, nose and throat Health products - Medical devices - Cardiovascular 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 Healthcare Recall class Type II Recall date

2026-04-08

Identification number RA-81918

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Last updated

Classification

Agency
Health Canada
Filed
April 22nd, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Medical device makers Healthcare providers Clinical investigators
Industry sector
3345 Medical Device Manufacturing
Activity scope
Product recall response Medical device distribution Surgical supply safety
Geographic scope
Canada CA

Taxonomy

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

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