Servo Humidifier 163 — Class II medical device recall Z-2374-2016
Terminated recall by Teleflex Medical, reported 2016-08-17, distributed nationwide. Cracks may occur at the 15mm and 22mm ISO female connector.
| Recall number | Z-2374-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2015-12-03 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,700 units |
| Reason classes | packaging |
| Lot numbers | 201450, 201451, 201452, 201504 |
| Model numbers | 01-06-8125-8, 6419365 |
Product
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
Reason for recall
Cracks may occur at the 15mm and 22mm ISO female connector.
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-2374-2016. 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.