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

Medline procedure kits contain catheters failing performance specifications

Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.

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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.

Plain-English summary

Medline Industries, LP is recalling medical procedure kits including the Chest Exploration ECMO kit (SKU DYNJ63789A), the Coronary/Artery Bypass Tray (DYNJ17321G) and the D&C/Cysto kit (DYNJ909989B), among the SKUs listed in the recall notice. The action covers 10,415 units.

During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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 FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States and to the United Arab Emirates, Barbados, Bermuda, the Bahamas and Canada among other markets. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.

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 — Surgical procedure kit
Hazard
Affected units
10,415

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

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Same hazard · out of specification

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