Class II — Plasma Surgical Inc.
| Recalling firm | PLASMA SURGICAL INC |
|---|---|
| Registered facility | PLASMA SURGICAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 36 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom. |
| Initiated | 2012-04-27 |
| Classified | 2012-06-11 |
| Terminated | 2012-11-01 |
| Recall number | Z-1794-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Plasma Surgical Inc. (Z-1794-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61951/
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