FDA-Device2026-09-02Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for potentially contaminated component
What this means
Medline has recalled four models of surgical convenience kits used in neurosurgery procedures because they contain a component that may be contaminated. The affected kits were distributed nationwide to healthcare facilities in 18 states.
- Check your facility's inventory against the affected lot numbers and SKUs listed in the recall notice.
- Do not use affected kits; isolate them from circulation.
- Contact Medline or the FDA if you have questions about which lots your facility received.
The agency's original wording
Hazard
Kits contain a potentially contaminated component which were recalled by the manufacturer
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Affected count
241 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3029-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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