Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review, indicating in-market product may be out-of-specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving endotoxin contamination, a high-risk hazard for sterile medical devices used in surgical/neurological procedures. No illnesses or injuries have been reported in the source text, but endotoxin presence in sterile surgical supplies represents a significant risk of harm.
Plain-English summary
Medline Industries, LP is recalling multiple medical procedure kits containing Medline Neuro Sponges. The kits include RR-OMFS PACK-LF, MEM MAXILLOFACIAL PACK-LF, and ORAL SURGERY PACK models with various SKU numbers. A total of 2,228 kits have been distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product. This indicates that in-market product may be out-of-specification for endotoxin. Affected lot numbers and detailed product codes are available through the FDA recall database.
Patients and healthcare facilities using these kits should contact Medline Industries, LP for instructions on return or replacement of affected products.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. O
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin-contamination
- sterile-product-failure
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 (20)
- Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407
- UDI/DI case 40195327267408
- Lot Number: 23JMB165
- Lot Number: 23CMH103
- Lot Number: 23BMH200
- Lot Number: 23BMB495
- Lot Number: 22KMH108
- Lot Number: 22KME285
- Lot Number: 23KMJ648
- Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713
- UDI/DI case 40195327643714
- Lot Number: 26BME013
- Lot Number: 25JMC725
- Lot Number: 25IMA571
- Lot Number: 25HMC497
- Lot Number: 25FMG199
- Lot Number: 25EMB523
- Lot Number: 25DMF918
- Lot Number: 25CMH298
- Lot Number: 24LMA598
Distribution
Distribution scope not specified by the agency.
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