RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set — Class II medical device recall Z-2320-2021
Terminated recall by Teleflex Medical Europe Ltd, reported 2021-08-25, distributed nationwide. The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained f
| Recall number | Z-2320-2021 |
|---|---|
| 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 | 2021-07-16 |
| Classified | 2021-08-19 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2026-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 155,030 units |
| Lot numbers | KME20K0001, KME20K0026, KME20K0360, KME20K0361, KME20K0449, KME20K0450, KME20K0465, KME20K0467, KME20K0765, KME20K0766, KME20K0768, KME20K0769, KME20K0770, KME20K0935, KME20K0939, KME20K0941, KME20K1148, KME20K1150, KME20K1202, KME20K1204, KME20K1304, KME20K1414, KME20K1550, KME20K1551, KME20K1552, KME20K1581, KME20K1582, KME20K1628, KME20K1658, KME20K1665, KME20K2057, KME20K2187, KME20K2188, KME20K2246, KME20K2622, KME20K2625, KME20K2920, KME20K3016, KME20K3018, KME20K3159 and 203 more |
Product
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Reason for recall
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
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-2320-2021. 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.