Teleflex MEDICAL LMA — Class II medical device recall Z-1628-2018
Terminated recall by Teleflex Medical Europe Ltd, reported 2018-05-09, distributed in TX. Teleflex Medical is recalling the affected product because there may be missing or incomplete information on t
| Recall number | Z-1628-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical Europe Ltd, Athlone, N/A, Ireland |
| Recall initiated | 2018-03-19 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-08-27 |
| Distributed | TX |
| Quantity | 25 units |
| Reason classes | labeling |
| Lot numbers | 161212 |
Product
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
Reason for recall
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
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-1628-2018. 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.