FDA Medical Device Recalls (openFDA)
MicroAire Surgical Instruments, LLC: Endotine Transbleph 3.5 (CFD-080-0167)
- Recall number
- Z-2294-2016
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Product
- Endotine Transbleph 3.5 (CFD-080-0167)
- Status
- Terminated
- Initiated
- 2016-05-06
- Posted
- not on file
- Terminated
- 2016-08-12
- 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).
- Root cause
- Labeling Change Control
- Action
- The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.
- Quantity
- 29
- Distribution
- The product was distributed in the United States and Sweden
- Lot, serial or model codes
- Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
- 510(k) numbers
- ["K042796"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 2020601
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28