Mucosal Atomization Device — Class II medical device recall Z-0898-2017
Terminated recall by Teleflex Medical, reported 2016-12-28, distributed nationwide. Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
| Recall number | Z-0898-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2016-10-27 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2020-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, SG, TH |
| Quantity | 2,674,650 units |
| Lot numbers | 160105, 160107, 160108, 160117, 160125, 160126, 160137, 160138, 160145, 160146, 160200, 160217, 160218, 160219, 160225, 160226, 160231, 160240, 160300, 160302, 160312, 160313, 160321, 160322, 160327, 160400, 160402, 160409, 160410, 160422, 160432, 160435, 160436, 160437, 160438, 160440, 160500, 160506, 160507, 160517 and 26 more |
Product
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
Reason for recall
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
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-0898-2017. 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.