The Recall Desk
HighFDA (Devices)·Z-2493-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ

Pending LLM rewrite. Source: FDA_DEVICE Z-2493-2026.

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) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU D
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)

  • DYNJ63789A: UDI/DI 10198459149771 (each)
  • 40198459149772 (case)
  • Lot Number 26BBD116
  • Lot Number 26ABL500
  • Lot Number 25FBH410
  • Lot Number 25EBQ051
  • Lot Number 25DBS969
  • Lot Number 24LBQ812
  • Lot Number 24LBF658
  • Lot Number 24JBM406
  • DYNJ17321G: UDI/DI 10193489323863 (each)
  • 40193489323864 (case)
  • Lot Number 23GBM492
  • Lot Number 22IBV269
  • Lot Number 22HBV981
  • Lot Number 22HBF916
  • DYNJ909989B: UDI/DI 10198459322686 (each)
  • 40198459322687 (case)
  • Lot Number 25GBW197
  • Lot Number 25GBD634

Distribution

Distributed nationwide across the United States.

Related recalls

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