The Recall Desk
HighFDA (Devices)·Z-2506-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH

Pending LLM rewrite. Source: FDA_DEVICE Z-2506-2026.

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: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see 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 DYNJ83242B: UDI/DI 10198459157028 (each)
  • 40198459157029 (case)
  • Lot Number 25HBR321
  • Lot Number 25GBD202
  • Lot Number 25FBK813
  • Lot Number 25EBG207
  • Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each)
  • 40195327193455 (case)
  • Lot Number 23FBK499
  • Lot Number 23EBV071
  • Lot Number 22KBK089
  • Lot Number 22IBV707
  • Lot Number 22HBC310
  • Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each)
  • 40195327451654 (case)
  • Lot Number 26DMG168
  • Lot Number 26CMD637
  • Lot Number 25KMC849
  • Lot Number 25JMA672
  • Lot Number 25DMC189

Distribution

Distributed nationwide across the United States.

Related recalls

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