CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Endotine Transbleph 3.5 (CFD-080-0167) recalled

MicroAire Surgical Instruments is recalling Endotine Transbleph 3.5 (CFD-080-0167). The recall was initiated on 6 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEndotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

Quantity recalled29

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2294-2016
FDA event ID: 74222
Recalling firm: MicroAire Surgical Instruments, Charlottesville, VA
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2016
FDA classified: 27 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

6 May 2016	Recall initiated by company
27 Jul 2016	Classified by FDA	+82 days
3 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

Endotine Transbleph 3.5 (CFD-080-0167)

Where it was distributed

The product was distributed in the United States and Sweden

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

The product was distributed in the United States and Sweden

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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