The Recall Desk
HighFDA (Devices)·Z-2508-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRAN

Pending LLM rewrite. Source: FDA_DEVICE Z-2508-2026.

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) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097
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 DYNJ908097: UDI/DI 10193489973846 (each)
  • 40193489973847 (case)
  • Lot Number 23FBQ975
  • Lot Number 23FBF166
  • Lot Number 23DBM780
  • Lot Number 22KBM832
  • Lot Number 22JBY524
  • Lot Number 22GBR089
  • Lot Number 22FBR153
  • Lot Number 22FBC633
  • Lot Number 22EBB478
  • Lot Number 22BBX706
  • Lot Number 22BBU902
  • Lot Number 22ABN864
  • Lot Number 21IBO640
  • SKU DYNJ908097A: UDI/DI 10195327507077 (each)
  • 40195327507078 (case)
  • Lot Number 24EBC216
  • Lot Number 24CBU878

Distribution

Distributed nationwide across the United States.

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