FDA Device recall Z-1012-2023
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff by Teleflex, citing potential for pilot balloon non-inflation or cuff non-deflation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1012-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-08 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
Reason
Potential for pilot balloon non-inflation or cuff non-deflation.
Identifiers
| code_info | Not distributed within the USA. a. Product Code, Batch Number (UDI): 112080-000065, KME21D2250 ((01)14026704195937(17)…Not distributed within the USA. a. Product Code, Batch Number (UDI): 112080-000065, KME21D2250 ((01)14026704195937(17)260328(10)KME21D2250), 112080-000080, KME21E1336 ((01)14026704195968(17)260428(10)KME21E1336); b. Product Code, Batch Number (UDI): 112082-000050, KME21F0726 ((01)14026704196019(17)260528(10)KME21F0726), 112082-000055, KME21E1231 ((01)14026704196026(17)260428(10)KME21E1231), 112082-000055, KME21F0945 ((01)14026704196026(17)260528(10)KME21F0945), 112082-000060, KME21E1395 ((01)14026704196033(17)260428(10)KME21E1395), 112082-000065, KME21F0383 ((01)14026704196040(17)260528(10)KME21F0383), 112082-000065, KME21F0833 ((01)14026704196040(17)260528(10)KME21F0833), 112082-000065, KME21F0931 ((01)14026704196040(17)260528(10)KME21F0931), 112082-000070, KME21E0582 ((01)14026704196057(17)260428(10)KME21E0582), 112082-000070, KME21E1267 ((01)14026704196057(17)260428(10)KME21E1267), 112082-000070, KME21E1350 ((01)14026704196057(17)260428(10)KME21E1350), 112082-000070, KME21F0435 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1012-2023%22
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