Class II — ConvaTec, Inc
| Recalling firm | ConvaTec |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 3,605,700 pieces |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland,… |
| Initiated | 2015-11-11 |
| Classified | 2016-03-03 |
| Terminated | 2016-07-18 |
| Recall number | Z-1044-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ConvaTec, Inc (Z-1044-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72823/
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