RecallRadar

FDA Device recall Z-1051-2015

MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg

On 2015-02-18 the FDA classified a Class I recall of MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg by Teleflex Medical, citing defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1051-2015
ClassificationClass I
Statusterminated
Initiated2015-01-12
Published2015-02-18
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionFL, KS, MI, WV

Product

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

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Identifiers

code_infoLot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1051-2015%22

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