FDA Device recall Z-1312-2026
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit by Medline Industries, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1312-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-24 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
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.
Identifiers
| code_info | Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2026%22
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