Quick Facts at a Glance
- Recall Date
- January 7, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Tracheostomy Kits
- Model numbers
- 1) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766, 2) DYKMBNDL55, Lot Number: 21DBB713, 3) DYKMBNDL55, Lot Number: 21CBH955 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
Tracheostomy kits are medical devices used to assist patients with breathing difficulties by providing an airway. These kits are utilized in hospitals and home care settings by patients requiring respiratory support.
Why This Is Dangerous
The recall stems from calibration issues in the sterilization process, which could lead to a lack of sterility in the devices. This raises the risk of infection for users.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may lead to significant health risks for users if devices are used without proper sterility. Patients and healthcare providers must act quickly to ensure safety.
Practical Guidance
How to identify if yours is affected
- Check if your tracheostomy kit matches the recalled model numbers
- Verify lot numbers against the recall list provided by Medline
- Inspect packaging for any notification of recall
Where to find product info
Model numbers and lot numbers can typically be found on the product packaging or in accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for processing your refund or replacement once the product is returned.
If the manufacturer is unresponsive
- Contact Medline customer service again
- Reach out to consumer protection agencies for assistance
- Consider documenting your request and seeking legal advice if necessary
How to prevent similar issues
- Always check for recalls before purchasing medical devices
- Ensure products have proper sterilization certification
- Consult healthcare providers about the safety of medical devices
Documentation advice
Keep copies of all correspondence with Medline, receipts of purchase, and any records of communications regarding the recall.
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Product Details
The recall includes three models: KIT STC TRACHEOSTOMY, Model Number DYKMBNDL55; KIT STC TRACHEOSTOMY, Model Number DYKMBNDL55A; and TRACH TOTE, Model Number DYNJ85691. These products were distributed worldwide, including across the United States.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 753 units
- Class II recall status
- High hazard level due to sterility concerns
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Safety Guide
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