Data Foundry

Medical device recalls 2016

Endotine Transbleph 3 — Class II medical device recall Z-2294-2016

Terminated recall by MicroAire Surgical Instruments, LLC, reported 2016-08-03. MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

Recall numberZ-2294-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMicroAire Surgical Instruments, LLC, Charlottesville, VA, United States
Recall initiated2016-05-06
Classified2016-07-27
Reported by FDA2016-08-03
Terminated2016-08-12
Countries outside the USSE
Quantity29
Reason classeslabeling
Lot numbers285373

Product

Endotine Transbleph 3.5 (CFD-080-0167)

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).

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-2294-2016. 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.