Medline Neurosponge Kits Recalled for Endotoxin Levels
Medline is recalling 3,468 neurosurgical convenience kits containing Pilling Wecksorb Neurosponges due to potential out-of-specification endotoxin levels.
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 3/5 (High).
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: The recall is classified as FDA Class II. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 3,468 medical convenience kits labeled as NEURO CDS, NEURO PACK, NEURO BUNDLE-LF, NEURO PACK-LF, NEURO LAMINECTOMY PACK, NEURO PACK SJ, and BASIC NEURO PACK. These kits contain Pilling Wecksorb Neurosponges and Neurosponge Strips. The recall is due to potential out-of-specification levels of endotoxin in the neurosponges.
The affected products were distributed nationwide in Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin, and Wyoming. Specific lot numbers and UDI/DI codes are listed in the official recall notice.
Healthcare facilities and consumers should stop using these kits and contact Medline Industries, LP for further instructions or a return. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 3,468
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 SKU CDS985246J
- UDI/DI 10193489232394 (each) 40193489232395 (case)
- Lot Number 22HMB295
- Lot Number 22IMB860
- Medline Kit SKU DYNJ32770V
- UDI/DI 10195327090111 (each) 40195327090112 (case)
- Lot Number 22FMB806
- Medline Kit SKU DYNJ40095D
- UDI/DI 10195327281250 (each) 40195327281251 (case)
- Lot Number 23GMI744
- Medline Kit SKU DYNJ42844D
- UDI/DI 10193489880564 (each) 40193489880565 (case)
- Lot Number 25EBV362
- Medline Kit SKU DYNJ45121I
- UDI/DI 10193489887631 (each) 40193489887632 (case)
- Lot Number 25CMH980
- Lot Number 25FMB096
- Lot Number 25GMA066
- Lot Number 25GMH940
- Lot Number 25BMI081
Distribution
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