FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline intermittent latex catheter recalled for connector detachment and surface defects

OTHERNationwide distribution

Medline latex catheter recalled for connector detachment risk

Medline identified quality issues in its 14 Fr intermittent latex catheter with pre-connected collection bag. Problems include rough spots on the catheter surface, connectors that may detach prematurely, and some catheters that don't meet size specifications.

  • Stop using the catheter if you have product number URO4RR14C
  • Contact your healthcare provider or Medline for a replacement or alternative
  • Check the product number on your catheter packaging to confirm if it is affected
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
8260 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2026

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