Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25"
Summary
The FDA issued a Class II for Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Epo by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .
Details
Source
Device Recall
External ID
Z-2008-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.
Lot/Code Info: 1. NEUROSPNG02: UDI/DI each 10197344111572, UDI/DI case 20197344111579, ALL LOTS; 2. NEUROSPNG05: UDI/DI each 20080196286659, UDI/DI case 30080196286656, ALL LOTS; 3. NEUROSPNG06: UDI/DI each 20080196286505, UDI/DI case 30080196286502, ALL LOTS; 4. NEUROSPNG07: UDI/DI each 10080196286485, UDI/DI case 40080196286486, ALL LOTS; 5. NEUROSPNG09: UDI/DI each 20080196286536, UDI/DI case 30080196286533, ALL LOTS; 6. NEUROSPNG11: UDI/DI each 20080196286550, UDI/DI case 30080196286557, ALL LOTS; 7. NEUROSPNG13: UDI/DI each 10080196286577, UDI/DI case 40080196286578, ALL LOTS; 8. NEUROSPNG14: UDI/DI each 10080196286584, UDI/DI case 40080196286585, ALL LOTS.
Quantity Affected: 4225160 units
Reason for Recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2008-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29