Medline Neuro Sponges in Spine Procedure Kits Recalled for Out-of-Specification Endotoxin
Medline is recalling Spine Pack-LF medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels detected during an internal review. The affected kits were distributed worldwide.
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 recall involving a sterile medical device with potential endotoxin contamination, which poses a risk of serious adverse health consequences (infection or sepsis) in surgical/procedural settings. The source text does not report illnesses or injuries, but the hazard is not merely theoretical given the contamination finding and the high-risk nature of implantable/invasive medical devices.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits labeled as SPINE PACK-LF (Kit Number/SKU PHS719414B) that contain Medline Neuro Sponges. The recall affects 104 kits with the following lot numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, and 21BBL371.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Neuro Sponge product, indicating that in-market product may be out-of-specification for endotoxin. These kits were distributed worldwide.
Healthcare facilities that received affected kits should stop using them and contact Medline for instructions on product return or replacement. Patients who may have received treatment involving these kits should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin-contamination
- sterile-device-defect
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 (8)
- UDI/DI each 10889942214112
- UDI/DI case 40889942214113
- Lot Numbers: 22GBF198
- 22DBU132
- 22ABJ303
- 21GBV167
- 21GBV186
- 21BBL371.
Distribution
Distribution scope not specified by the agency.
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