FDA Device recall Z-1044-2016

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered…

FDA Device
Class II
terminated
Published 2016-03-09

On 2016-03-09 the FDA classified a Class II recall of Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered… by Convatec, citing the Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1044-2016
Classification	Class II
Status	terminated
Initiated	2015-11-11
Published	2016-03-09
Last updated	2026-09-13 11:54 UTC
Company	Convatec
Distribution	US

Product

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

Reason

The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

Identifiers

code_info	lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97… lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840, 98841, 98843, 98844, 98853, 98856, 98859, 98867, 98868, 98869, 98870, 98871, 98969, 99078, 99079, 99199, 99206, 99207, 99227, 99230, 99231, 99232, 99297, 99397, 99398, 99447, 99450, 99451, 99466, 99492, 99539, 99577, 99578, 99591, 99606, 99628, 99630, 99631, 99642, 99661, 99673, 99674, 99708, 99709, 99735, 99845, 99852, 99853, 99854, 99919, 99920, 99928, 99932, 99997, 100029, 100065, 100066, 100074, 100077, 100101, 100102, 100114, 100119, 100155, 100167, 100177, 100180, 100205, 100206, 100207, 100238, 100254, 100401, 100402, 100424, 100483, 100506, 100516, 100546, 100549, 100552, 100563, 100599, 100603, 100693, 100697, 100700, 100705, 10

code_info

lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97…

lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840, 98841, 98843, 98844, 98853, 98856, 98859, 98867, 98868, 98869, 98870, 98871, 98969, 99078, 99079, 99199, 99206, 99207, 99227, 99230, 99231, 99232, 99297, 99397, 99398, 99447, 99450, 99451, 99466, 99492, 99539, 99577, 99578, 99591, 99606, 99628, 99630, 99631, 99642, 99661, 99673, 99674, 99708, 99709, 99735, 99845, 99852, 99853, 99854, 99919, 99920, 99928, 99932, 99997, 100029, 100065, 100066, 100074, 100077, 100101, 100102, 100114, 100119, 100155, 100167, 100177, 100180, 100205, 100206, 100207, 100238, 100254, 100401, 100402, 100424, 100483, 100506, 100516, 100546, 100549, 100552, 100563, 100599, 100603, 100693, 100697, 100700, 100705, 10

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.