Portex Endotracheal Tube — Class I medical device recall Z-1289-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2025-03-19, distributed nationwide. Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to
| Recall number | Z-1289-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-12 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 15019315018633, 15019315018640, 15019315018657, 15019315018831, 15019315018848, 15019315018855, 15019315018862, 15019315019029, 15019315019036, 15019315019043, 15019315019807, 15019315019814, 15019315019821, 15019315056758, 15019315056765, 15019315056772 |
| Lot numbers | 100/105/030, 100/105/035, 100/111/020, 100/111/025, 100/111/030, 100/111/035, 100/126/025, 100/126/030, 100/126/035, 100/127/025, 100/127/030, 100/127/035, 100/141/025, 100/141/030, 100/141/035, 3867278, 3867283, 3872612, 3874369, 3874374, 3874375, 3874389, 3874397, 3874416, 3874417, 3877711, 3877721, 3877722, 3880748, 3880750, 3880755, 3884332, 3884360, 3891574, 3891578, 3891587, 3891590, 3891596, 3891597, 3891631 and 460 more |
| Model numbers | 100/105/025, 100/105/030, 100/105/035, 100/111/020, 100/111/025, 100/111/030, 100/111/035, 100/126/025, 100/126/030, 100/126/035, 100/127/025, 100/127/030, 100/127/035, 100/141/025, 100/141/030, 100/141/035 |
Product
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Reason for recall
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
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-1289-2025. 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.