FDA Devices recall · Reported February 18, 2015
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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.
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
Teleflex Medical recalled MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, … - a critical-severity action.
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, … was recalled by Teleflex Medical in February 18, 2015. Reason: Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female co…. Check the official notice for the remedy. Verify recall #Z-1051-2015 with the FDA Devices before acting.
The recall
Teleflex Medical issued this critical-severity FDA Devices recall-Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female co….
- Critical
- severity level
- 100 units
- affected scope
- Class I
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1051-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1051-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on January 12, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 100 units.
The documented reason for this recall is: Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector. Distribution data in the federal record shows the product reached: Distributed to FL, KS, MI and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1051-2015 |
| Date reported | February 18, 2015 |
| Date initiated | January 12, 2015 |
| Recalling firm | Teleflex Medical |
| Firm location | Durham, NC |
| Affected scope | 100 units |
| Distribution | Distributed to FL, KS, MI and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1051-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026