FDA Device recall Z-2294-2016
Endotine Transbleph 3.5 (CFD-080-0167)
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Endotine Transbleph 3.5 (CFD-080-0167) by Microaire Surgical Instruments, citing microAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2294-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-06 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microaire Surgical Instruments |
| Distribution | n/a |
Product
Endotine Transbleph 3.5 (CFD-080-0167)
Reason
MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Identifiers
| code_info | Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2294-2016%22
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