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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61951

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

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Event summary

Timeline bucket
April 27, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Plasma Surgical 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

PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.

Z-1794-2012
Recall number
Z-1794-2012
Initiated
April 27, 2012
Classification
Class II
Status
Terminated
Recalling firm
Plasma Surgical Inc.
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in 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

Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.

Code information

Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.