The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2495-2026·Announced 2026-06-24

Medline urethroplasty kits contain catheters failing performance specifications

Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.

Plain-English summary

Medline Industries, LP is recalling urethroplasty procedure kits, covering the Kit Urology Urethroplasty (DYKMBNDL117C) and the Urethroplasty kits (DYNJ908978, DYNJ908978F). The action covers 91 units.

During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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 FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.

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 — Surgical procedure kit
Hazard
Affected units
91

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

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