The Recall Desk
HighFDA (Devices)·Z-2495-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU D

Pending LLM rewrite. Source: FDA_DEVICE Z-2495-2026.

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 Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
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 (14)

  • Medline Kit Number/SKU DYKMBNDL117C: UDI/DI 10195327371104 (each)
  • 40195327371105 (case)
  • Lot Number 23DLA834
  • Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each)
  • 40195327231133 (case)
  • Lot Number 23BMC463
  • Lot Number 23AMA685
  • Lot Number 23AMB905
  • Lot Number 22LMG466
  • Lot Number 22LMB983
  • Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each)
  • 40198459228804 (case)
  • Lot Number 25JBD225
  • Lot Number 25HBW236.

Distribution

Distributed nationwide across the United States.

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