FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects

OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline identified that certain batches of carotid neuro and VP shunt procedure kits did not meet performance specifications. Issues include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameter measurements.

  • Check if your facility has received affected kits with the listed lot numbers.
  • Do not use affected kits for procedures.
  • Contact Medline for instructions on returning or replacing the kits.
  • Consult the full recall notice for complete lot numbers and UDI codes.
Hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
342 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2500-2026

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