The Recall Desk
HighFDA (Devices)·Z-2488-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2

Pending LLM rewrite. Source: FDA_DEVICE Z-2488-2026.

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) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905
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 DYNJ912271: UDI/DI 10198459688324 (each)
  • 40198459688325 (case)
  • Lot Number 26CBQ109
  • Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each)
  • 40193489957991 (case)
  • Lot Number 25FBO720
  • Lot Number 24KBO387
  • Lot Number 24KBO015
  • Lot Number 24KBD819
  • Lot Number 24KBA736
  • Lot Number 24FBG144
  • Lot Number 24DBO838
  • Lot Number 24BBC453
  • Lot Number 24ABM118
  • Lot Number 23KBS950
  • Lot Number 23IBC670
  • Lot Number 22LBN883
  • Lot Number 22KBF121
  • Lot Number 22IBN293
  • Lot Number 22FBO695

Distribution

Distributed nationwide across the United States.

Related recalls

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