FDA recall, , Moderate risk
Medline Suction Catheter Kits and Intubation Tray
Medline Suction Catheter Kits and Intubation Tray may contain a smaller 8 Fr catheter, which can cause airway obstruction.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP of Northfield, Illinois, recalled Medline 14 Fr Suction Catheter Kits and Intubation Tray (Adult) containing Suction Catheter Kits because 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.
The company began the recall on December 24, 2025, and the FDA added it to its Enforcement Report on February 6, 2026. The products were distributed nationwide in the US and Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
2 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
- UDI-DI
- 10198459480317
- 40198459480318
- Lot code
- 25IBC172
- 25HBJ413
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- UDI-DI
- 48625040001
- 10080196033317
- 40080196033318
Recall details
- Company began the recall
- Sold in
Distribution US nationwide and Canada.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98285
- Recall numbers
- Z-1312-2026 to Z-1313-2026
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
