FDA DevicesClass II
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Published: February 18, 2026Recall ID: Z-1313-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Affected Products
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98285 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318 |
| Postal code | 60093-2753 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 130 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251224 |
| Initial firm notification | Letter |
| Center classification date | 20260206 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionDistribution US nationwide and Canada.