CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Medline Suction Catheter Kits recalled by Medline Industries
Medline Industries is recalling Medline Suction Catheter Kits, distributed nationwide in the US. The recall was initiated on 24 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1312-2026
- FDA event ID
- 98285
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Dec 2025
- FDA classified
- 6 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 24 Dec 2025 | Recall initiated by company | |
| 6 Feb 2026 | Classified by FDA | +44 days |
| 18 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Where it was distributed
Distribution US nationwide and Canada.
Questions about this recall
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.
Which lots are affected?
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Where was it sold?
Distribution US nationwide and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98285| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Intubation Tray (Adult) containing Suction Catheter Kits recalled | Medline Industries | Device Malfunction | Nationwide |
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Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |