Plasma Surgical Inc.: Medical Device Recall in 2012 - (Recall #: Z-1794-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 27, 2012

Date Posted: June 20, 2012

Recall Number: Z-1794-2012

Event ID: 61951

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.

Status: Terminated

Product Quantity: 36 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated