Recall Z-1313-2026 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Medline Industries, LP
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
| Date | Feb 6, 2026 (initiated Dec 24, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply. |
| Quantity | 130 |
| Distribution | Distribution US nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.