Medline Medical Convenience Kits Recalled for Endotoxin Levels
Medline is recalling 246 surgical 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 involves a risk-of-harm product (endotoxin contamination in surgical kits) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medline Industries, LP is recalling 246 medical convenience kits, including Craniotomy, Ortho Spine, ENT Sinus, and Thyroid ENT packs. These kits contain Pilling Wecksorb Neurosponges and Neurosponge Strips that may have out-of-specification levels of endotoxin.
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 codes are listed in the recall documentation.
Healthcare facilities and consumers should stop using the affected kits and contact Medline for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 246
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 SKU Number DYNJT6545
- UDI 10198459558757 (each) 40198459558758 (case)
- Lot Number 25JMG396
- Lot Number 26AMH848
- Medline SKU Number DYNJ88056A
- UDI 10198459372667 (each) 40198459372668 (case)
- Lot Number 25FMD894
- Medline SKU Number DYNJ89001
- UDI 10198459258961 (each) 40198459258962 (case)
- Lot Number 25JMH786
- Lot Number 25KMF523
- Lot Number 25KMF530
- Lot Number 26CMD479
- Medline SKU Number DYNJ908641
- UDI 10195327123819 (each) 40195327123810 (case)
- Lot Number 24ABD437
- Lot Number 24ABO388
- Lot Number 23EBA762
- Lot Number 23HBG168
- Lot Number 23KBW672.
Distribution
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