MAQUET Servo Humidifier 163 — Class I medical device recall Z-1008-2015
Terminated recall by Teleflex, Inc., reported 2015-02-18, distributed in FL, KS, MI, WV. Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in th
| Recall number | Z-1008-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex, Inc., Wayne, PA, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2015-02-06 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2017-03-21 |
| Distributed | FL, KS, MI, WV |
| Quantity | 18 |
| Reason classes | packaging |
| Lot numbers | 201321, 201323, 201324 |
| Model numbers | 01-06-8125-8, XKC01-06-8125-8 |
Product
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial 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 humidify gases breathed in by a patient.
Reason for recall
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
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-1008-2015. 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.