FDA Medical devices recall ·
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory… recall
- Recall number
- Z-1312-2026
- Date
- (initiated December 24, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 141,971
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Distribution
Distribution US nationwide and Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1312-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.