Agency classClass IIOur severity:High FDA (Devices)·Z-1044-2016·Announced 2016-03-09

ConvaTec Recalls Opti-Mist Nebulizer Masks Due to Reduced Aerosol Output

ConvaTec is recalling Opti-Mist and Opti-Mist Clear nebulizer masks because a component defect reduces or stops aerosol output, potentially preventing patients from receiving medication.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failure that prevents the delivery of medication. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ConvaTec, Inc. is recalling approximately 3.6 million units of Opti-Mist and Opti-Mist Clear nebulizer masks. These devices are intended to spray liquids in aerosol form into gases that are delivered directly to a patient. The recall covers specific lot and batch numbers, including 13-23, 13-24, 13-29, and numerous others listed in the official notice.

The recall was initiated because the nebulizer masks malfunction by producing reduced or no aerosol output. This issue is caused by a reduction in the diameter of a component part inside the nebulizer. If the device fails to produce aerosol, patients may not receive their intended medication.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, Germany, and the United Kingdom. Consumers and healthcare providers should check their nebulizer masks against the list of affected lot and batch numbers. If a device is affected, it should be stopped from use and returned to the manufacturer or distributor for replacement or refund.

The recalled product

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.
Manufacturer: ConvaTec, Inc
Category: Medical Device — Respiratory / Nebulizer
Hazard: device-malfunction
medication-delivery-failure
Affected units: 3,605,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Same manufacturer · ConvaTec, Inc

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