FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline urethral catheterization trays recalled for connector detachment and diameter defects

OTHERNationwide distributionMedical devices

What this means

Medline identified that some urethral catheterization trays (15 Fr size, product numbers DYNC1816 and DYND10350) did not meet quality standards. Problems include irregular catheter surface finish, connectors that may detach prematurely from the catheter funnel, and some catheters with incorrect outer diameter.

  • Check your facility or home supply for the recalled product numbers DYNC1816 or DYND10350.
  • Contact Medline with questions or to report any issues at the number on your product packaging.
Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
8327756 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2480-2026

More Medline recalls

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Free · One email a week · Unsubscribe anytime
By signing up you agree to our Terms and Privacy Policy.