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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91287

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

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Event summary

Timeline bucket
November 28, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DeRoyal Industries Inc

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

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Z-0906-2023
Recall number
Z-0906-2023
Initiated
November 28, 2022
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

Code information

GTIN 50749756373222, Lots: 57466936 exp 8/1/2026; Lot 57897761 exp 6/1/2026

Distribution pattern

Distribution in US states of VA, and SC.