Medline Neuro Sponges recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling 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. Reason: 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.
What is being recalled
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.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2008-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 19, 2026 |
| Reported | May 6, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4225160 units |
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