Class II U.S. Food and Drug Administration

Medline Medical Procedure Kits labeled as: Adult Tracheostomy Tube recall: During an internal review, Medline identified representative samples did

Recall published 4 months ago

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 hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2491-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
217390 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22FBM309; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22DBJ094; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22OBH091; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 21HBC428; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 24ABC426; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23JBM836; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23HBS357; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22KBS784; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22IBV574; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 26ABH211; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25GBS702; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25EBT418; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24LBP073; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24JBI868; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24HBW417; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24EBV861; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26CMK753; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMF647; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMB840; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25KMD227; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25JMB620; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25HME486; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25GMA169; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25EME427; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25CMG490; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25BMC915; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25AMD126; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMJ170; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMA267; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24IMH206; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMI841; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMA214; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24FMH462; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EMJ672; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EME216; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24DMK415; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24CMA…
UPC codes
10653160327134, 40653160327135, 10195327207083, 40195327207084, 10195327689100, 40195327689101, 10193489784824, 40193489784825

Products covered by this recall

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)

Check your product

The notice names 32 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10653160327134
  • 40653160327135
  • 10195327207083
  • 40195327207084
  • 10195327689100
  • 40195327689101
  • 10193489784824
  • 40193489784825

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 22FBM309
  • 22DBJ094
  • 22OBH091
  • 21HBC428
  • 24ABC426
  • 23JBM836
  • 23HBS357
  • 22KBS784
  • 22IBV574
  • 26ABH211
  • 25GBS702
  • 25EBT418
  • 24LBP073
  • 24JBI868
  • 24HBW417
  • 24EBV861
  • 26CMK753
  • 26BMF647
  • 26BMB840
  • 25KMD227

Model or item number

On the rating label, the box or the instruction sheet.

  • MNS12180
  • DYNJ67109B
  • DYNJ67109D
  • PHS41719A

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10653160327134, 40653160327135, 10195327207083; lot code 22FBM309, 22DBJ094, 22OBH091; model number MNS12180, DYNJ67109B, DYNJ67109D. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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