Medline Neuro Sponges recalled for out-of-specification endotoxin levels
Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as a Class II recall. The source text states only that endotoxin levels are out-of-specification with no reported illnesses or injuries, making this a precautionary recall based on a detected deviation rather than confirmed harm.
Plain-English summary
Medline Industries, LP is recalling Medline Neuro Sponges in eight size variations (ranging from 0.25" X 0.25" to 1" X 3"), distributed worldwide. The recall affects approximately 4,225,160 units across all lot numbers for each SKU.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Neuro Sponge product sample. This indicates that in-market product may be out-of-specification for endotoxin content.
Healthcare facilities and practitioners who have received these products should contact Medline Industries for further guidance. Specific UDI/DI codes and lot information for each of the eight affected SKUs are available through the FDA or Medline.
The recalled product
- Product
- 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.…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 4,225,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 1. NEUROSPNG02: UDI/DI each 10197344111572
- UDI/DI case 20197344111579
- ALL LOTS
- 2. NEUROSPNG05: UDI/DI each 20080196286659
- UDI/DI case 30080196286656
- 3. NEUROSPNG06: UDI/DI each 20080196286505
- UDI/DI case 30080196286502
- 4. NEUROSPNG07: UDI/DI each 10080196286485
- UDI/DI case 40080196286486
- 5. NEUROSPNG09: UDI/DI each 20080196286536
- UDI/DI case 30080196286533
- 6. NEUROSPNG11: UDI/DI each 20080196286550
- UDI/DI case 30080196286557
- 7. NEUROSPNG13: UDI/DI each 10080196286577
- UDI/DI case 40080196286578
- 8. NEUROSPNG14: UDI/DI each 10080196286584
- UDI/DI case 40080196286585
- ALL LOTS.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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