Medline Neurosurgical Kits Recalled for Endotoxin Contamination
Medline is recalling 974 neurosurgical convenience kits containing 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, and the hazard involves a high-risk pathogen (endotoxin) in a medical device without reported illnesses, which aligns with the 'High' severity criteria.
Plain-English summary
Medline Industries, LP is recalling 974 medical convenience kits, including Laminectomy, Ortho Spine, Neuro Spine, and Craniotomy packs, due to potential out-of-specification levels of endotoxin in the Pilling Wecksorb Neurosponges and Neurosponge Strips contained within the kits.
The affected kits 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 for the affected SKUs are listed in the recall documentation.
Healthcare facilities and consumers should check their inventory for the specific SKUs and lot numbers identified in the recall notice. If the affected products are found, they should be removed from use and returned to Medline Industries, LP according to the company's instructions.
The recalled product
- Product
- Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 974
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 DYNJT6548
- UDI/DI 10198459558764 (each) 40198459558765 (case)
- Lot Number 25JMF561
- Medline Kit SKU DYNJ44504G
- UDI/DI 10198459241956 (each) 40198459241957 (case)
- Lot Number 25EDA305
- Lot Number 25EDB254
- Medline Kit SKU DYNJ45419F
- UDI/DI 10195327625689 (each) 40195327625680 (case)
- Lot Number 24JMF418
- Lot Number 24JMJ129
- Medline Kit SKU DYNJ46024F
- UDI/DI 10195327237011 (each) 40195327237012 (case)
- Lot Number 23HBJ773
- Medline Kit SKU DYNJ54479C
- UDI/DI 10193489460254 (each) 40193489460255 (case)
- Lot Number 23HBA720
- Medline Kit SKU DYNJ58006B
- UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot Number 23BMC930
Distribution
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