The Recall Desk
HighFDA (Devices)·Z-2486-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2)

Pending LLM rewrite. Source: FDA_DEVICE Z-2486-2026.

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) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDI
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 DYNJ67331B: UDI/DI 10195327013837 (each)
  • 40195327013838 (case)
  • Lot Number 23JBM539
  • Lot Number 23IBF088
  • Lot Number 23FBM203
  • Lot Number 22JBK233
  • Lot Number 22JBB115
  • Lot Number 22IBO304
  • Lot Number 22HBR331
  • Lot Number 22FBM460
  • Lot Number 22DBS093
  • Lot Number 22CBJ072
  • Lot Number 22BBX288
  • Lot Number 21LBU240
  • Lot Number 21JBP452
  • Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each)
  • 40198459646103 (case)
  • Lot Number 26CBD487
  • Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each)
  • 40889942885658 (case)

Distribution

Distributed nationwide across the United States.

Related recalls

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