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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91165

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

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Event summary

Timeline bucket
November 18, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ConMed Corporation

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

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

Z-0474-2023
Recall number
Z-0474-2023
Initiated
November 18, 2022
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
23,700 US; 5,225 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

Code information

UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084

Distribution pattern

Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.