FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
- Recall number
- Z-2999-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
- Status
- Open, Classified
- Initiated
- 2026-07-10
- Posted
- 2026-08-21
- Terminated
- not on file
- Reason
- Component labeling discrepancy
- Root cause
- Labeling Change Control
- Action
- Medline Industries issued an URGENT MEDICAL DEVICE CORRECTION notice to its sole consignee on 7/10/2026 via USPS and email. The notice explained the issue, potential risk, and attached the notice from Medtronic. The notice from Medtronic provided the following information: "Customer Actions: " Customers can continue to use the Covidien Shiley" disposable decannulation plugs. " Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue. " Share this notice with all relevant personnel within your organization, and with any organization to which the affected product has been transferred or distributed." Medline requested a response through their portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-115-FGX2.
- Quantity
- 45 kits
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFR
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28