The Recall Desk
HighFDA (Devices)·Z-2500-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ4492

Pending LLM rewrite. Source: FDA_DEVICE Z-2500-2026.

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) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
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 DYNJ44926G: UDI/DI 10193489766554 (each)
  • 40193489766555 (case)
  • Lot Number 24EBH848
  • Lot Number 24DBK995
  • Lot Number 23JBP023
  • Lot Number 23HBR067
  • Lot Number 23FBM330
  • Lot Number 23EBK061
  • Lot Number 22JBG042
  • Lot Number 22GBH864
  • Lot Number 22DBT571
  • Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each)
  • 40195327684663 (case)
  • Lot Number 25DMJ438
  • Lot Number 25CMH178
  • Lot Number 24IME720
  • Lot Number 24HMG912
  • Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each)
  • 40198459518974 (case)
  • Lot Number 26CMC503

Distribution

Distributed nationwide across the United States.

Related recalls

Same category