FDA-Device2026-02-04Class IIPACKAGING DEFECT

Medline neurosurgery procedure kits recalled for cracked adhesive tubing

OTHERNationwide distribution

Stop using affected Medline neuro procedure kits

Medline distributed six types of neurosurgery procedure convenience kits containing MASTISOL liquid adhesive. The tubing in the adhesive vials can crack when opened, which may compromise the sterility or usability of the kit. No injuries have been reported.

  • Check if you have any of the six affected kit types (DEPAUL BASIC NEURO-LF, NEURO MINOR PACK, NEURO SHUNT PACK, NEURO PACK, NEURO BASIC, or PK NEURO SHUNT BUMC).
  • Verify the lot number on your kit against the recalled batches listed in the recall notice.
  • Stop using any matching kits and contact Medline or your healthcare facility's supply chain for instructions on return or replacement.
  • Report any use of a cracked or compromised kit to your facility's quality or safety officer.
Hazard

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Sold states
US Nationwide distribution.
Affected count
236 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO SHUNT BUMC, Kit SKU DYNJT6428.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1196-2026

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