The Recall Desk
HighFDA (Devices)·Z-2497-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see th

Pending LLM rewrite. Source: FDA_DEVICE Z-2497-2026.

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 BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
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)

  • Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each)
  • 40193489684026 (case)
  • Lot Number 22CMD618
  • Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each)
  • 40195327242399 (case)
  • Lot Number 23BBK690
  • Lot Number 23ABK356
  • Lot Number 23ABG037
  • Lot Number 22IBL708
  • Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each)
  • 40195327350728 (case)
  • Lot Number 24GBK706
  • Lot Number 24GBH415
  • Lot Number 24FBQ282
  • Lot Number 24FBC513
  • Lot Number 23KBK097
  • Lot Number 23DBF286
  • Lot Number 23CBI425
  • Medline Kit Number/SKU DYNJ83242C: UDI/DI 10198459575655 (each)
  • 40198459575656 (case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category