The Recall Desk
HighFDA (Devices)·Z-2479-2026·Announced 2026-06-24

[pending] MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. D

Pending LLM rewrite. Source: FDA_DEVICE Z-2479-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr;
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. DYND13508
  • UDI/DI 10080196031139 (each)
  • 20080196031136 (case)
  • 2. DYND13510
  • UDI/DI 10080196726462 (each)
  • 40080196726463 (case)
  • 3. DYND13512
  • UDI/DI 10080196031177 (each)
  • 40080196031178 (case)
  • 4. DYND13514
  • UDI/DI 10080196726219 (each)
  • 40080196726210 (case)
  • 5. DYND13515
  • UDI/DI 10080196031214 (each)
  • 40080196031215 (case)
  • 6. DYND13516
  • UDI/DI 10080196031221 (each)
  • 40080196031222 (case)
  • 7. DYND13518
  • UDI/DI 10080196031245 (each)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category