Medline Recalls Neurosurgical Convenience Kits Due to Contamination
Medline Industries is recalling 241 neurosurgical convenience kits distributed nationwide because they contain a potentially contaminated component.
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 potentially contaminated medical device component where no specific illnesses or injuries are reported in the source text, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 241 convenience kits used for neurosurgical procedures, including LAMI FUSION, NON MB MJR NEURO CRANI SM PK, CRANIOTOMY, and KIT CRANIOTOMY RFD. The recall was initiated because the kits contain a potentially contaminated component.
The affected products were distributed nationwide in the states of Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, and Wisconsin. Specific lot numbers and UDI/DI codes are available in the structured product information.
Healthcare facilities and consumers should stop using these kits and contact Medline Industries for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 241
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 (15)
- Medline Kit SKU CDS982035Y
- UDI/DI 10198459385636 (each) 40198459385637 (case)
- Lot Number 25LMF531
- Lot Number 25JML577
- Medline Kit SKU DYNJT6104
- UDI/DI 10198459539374 (each) 40198459539375 (case)
- Lot Number 25JBM473
- Medline Kit SKU DYNJ903471I
- UDI/DI 10198459255069 (each) 40198459255060 (case)
- Lot Number 26DDB085
- Lot Number 26DDA481
- Lot Number 26CDA102
- Medline Kit SKU DYNJ906496K
- UDI/DI 10198459419614 (each) 40198459419615 (case)
- Lot Number 25KLA074.
Distribution
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