FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline Tonsil Pack Cath medical procedure kits recalled for catheter defects

OTHERNationwide distribution

Medline Tonsil Pack Cath kits recalled for catheter defects

Medline identified quality issues in certain lots of its Tonsil Pack Cath medical procedure kits. Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and dimensional specifications not being met in some units.

  • Check if you have Medline Tonsil Pack Cath (SKU DYNJ65199A) with lot numbers: 23HMI132, 23HMA956, 23GMA525, 23DMF610, 23AMH680, or 22CBF155.
  • Do not use affected kits.
  • Return them to your Medline supplier or contact Medline Industries for further instructions.
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
384 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2494-2026

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief