Quick Facts at a Glance
- Recall Date
- December 24, 2025
- 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
- Suction Catheter Kits
- Model numbers
- Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 24, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
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
The Medline 14 Fr Suction Catheter Kit is used for respiratory procedures. It is designed to assist in clearing airways in patients requiring suctioning. Healthcare professionals commonly use these kits in emergency and critical care settings.
Why This Is Dangerous
A smaller catheter, the 8 Fr, may have been mistakenly packaged instead of the necessary 14 Fr catheter. The use of the smaller catheter can lead to airway obstruction, hypoxia, or respiratory failure, which requires immediate medical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the affected suction catheter kits to prevent serious health risks. The recall emphasizes the importance of using the correct size catheter during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the suction catheter kit.
- Look for UDI codes 10080196033317 for each unit and 40080196033318 for cases.
- Confirm that the product is the Medline 14 Fr Suction Catheter Kit.
Where to find product info
The lot number and UDI codes are typically found on the packaging of the product.
What timeline to expect
Refund processing may take 4-6 weeks after the product is returned.
If the manufacturer is unresponsive
- Contact Medline Industries again for follow-up.
- Document all correspondence related to the recall.
- Consider reporting the issue to the FDA if there is no response.
How to prevent similar issues
- Always verify the size and specifications of medical devices before use.
- Check for recall notices on medical devices regularly.
- Consult with healthcare providers for alternative products when necessary.
Documentation advice
Keep records of your purchase, correspondence with Medline, and any medical consultations related to the recall.
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Product Details
The recalled product is the Medline 14 Fr Suction Catheter Kits, SKU DYND40972. The affected lot number is 48625040001, with UDI codes 10080196033317 (each) and 40080196033318 (case). These kits were distributed across the United States and Canada.
Key Facts
- Hazard: respiratory failure risk
- Stop use immediately
- Contact Medline for refund instructions
- Distributed nationwide and in Canada
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Safety Guide
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