FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects and connector failure risk

OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline identified quality issues in several medical procedure kits during an internal review. Some catheters had surface irregularities, connectors that detached prematurely, or outer diameters that did not meet specifications. The affected kits include tracheostomy tube inserts, T&A kits, ear packs, and other surgical procedure kits.

  • Check the lot number on your medical procedure kit against the FDA recall notice.
  • Contact Medline or your healthcare facility if you have an affected kit.
  • Do not use affected kits until you have confirmed they are not on the recall list.
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
217390 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2491-2026

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