RUSCH¿ POLARIS" Laryngoscope — Class II medical device recall Z-1294-2021
Terminated recall by TELEFLEX MEDICAL INC, reported 2021-03-31, distributed nationwide. Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngosco
| Recall number | Z-1294-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX MEDICAL INC, Morrisville, NC, United States |
| Recall initiated | 2021-02-18 |
| Classified | 2021-03-23 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2026-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 14026704662552, 14026704662569, 14026704662576, 24026704662559, 24026704662566, 24026704662573, 34026704662556, 34026704662563, 34026704662570 |
| Lot numbers | 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T |
| Model numbers | 44401, 44402, 44403 |
Product
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Reason for recall
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
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-1294-2021. 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.