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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74222

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 06, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MicroAire Surgical Instruments, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Endotine Transbleph 3.5 (CFD-080-0167)

Z-2294-2016
Recall number
Z-2294-2016
Initiated
May 06, 2016
Classification
Class II
Status
Terminated
Quantity
29

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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

Distribution pattern

The product was distributed in the United States and Sweden