Medline DYNJAAHME23Recalls & reported problems

Medline Industries, Inc. · DBD-HME,FILTER,ADULT,ANG · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Oct 11, 2023Open, Classified
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Z-0369-2024 · Root cause: Device Design · FDA record ↗

Device details

UDI-DI	`10888277333383`
Brand	Medline
Model	DYNJAAHME23
Company	Medline Industries, Inc.
Product code	CAH · Filter, bacterial, breathing-circuit
Class	Class 2
FDA submission	K033008
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 22, 2021

Device type (GMDN): Heat/moisture exchanger/microbial medical gas filter

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

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All Filter, bacterial, breathing-circuit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.