Medline 14 Fr Suction Catheter Kits SKU DYND40972 — Class II medical device recall Z-1312-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-18, distributed nationwide. A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the
| Recall number | Z-1312-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-24 |
| Classified | 2026-02-06 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 141,971 |
| UPC / GTIN / UDI-DI | 10080196033317, 40080196033318 |
| Lot numbers | 48625040001 |
Product
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1312-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.