Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are… — Class II medical device recall Z-1044-2016
Terminated recall by ConvaTec, Inc, reported 2016-03-09, distributed nationwide. The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the
| Recall number | Z-1044-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2015-11-11 |
| Classified | 2016-03-03 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-07-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, DK, EE, EG, FI, FR, GB, IL, IT, JO, KE, KW, NL, NO, RU, SA, SE, VN |
| Quantity | 3,605,700 units |
| Reason classes | device malfunction |
| Lot numbers | 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, 100752, 100759, 100784, 100809, 100812, 100814 and 460 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1044-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.