MicroAire Surgical Instruments, LLC: Medical Device Recall in 2016 - (Recall #: Z-2294-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

Endotine Transbleph 3.5 (CFD-080-0167)

Product Classification:

Class II

Date Initiated: May 6, 2016
Date Posted: August 3, 2016
Recall Number: Z-2294-2016
Event ID: 74222
Reason for Recall:

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).

Status: Terminated
Product Quantity: 29
Code Information:

Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

Distribution Pattern:

The product was distributed in the United States and Sweden

Voluntary or Mandated:

Voluntary: Firm initiated