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.
What this means for you
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. Neu
- 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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