The Recall Desk
Severity pendingFDA (Devices)·Z-2491-2026·Announced 2026-06-24

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SI

Pending LLM rewrite. Source: FDA_DEVICE Z-2491-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
Manufacturer
Medline Industries, LP

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 MNS12180: UDI/DI 10653160327134 (each)
  • 40653160327135 (case)
  • Lot Number 22FBM309
  • Lot Number 22DBJ094
  • Lot Number 22OBH091
  • Lot Number 21HBC428
  • Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each)
  • 40195327207084 (case)
  • Lot Number 24ABC426
  • Lot Number 23JBM836
  • Lot Number 23HBS357
  • Lot Number 22KBS784
  • Lot Number 22IBV574
  • Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each)
  • 40195327689101 (case)
  • Lot Number 26ABH211
  • Lot Number 25GBS702
  • Lot Number 25EBT418
  • Lot Number 24LBP073
  • Lot Number 24JBI868

Distribution

Distributed nationwide across the United States.