PlasmaJet Open Surgery Handpiece — Class II medical device recall Z-1794-2012
Terminated recall by Plasma Surgical Inc., reported 2012-06-20, distributed nationwide. Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leak
| Recall number | Z-1794-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Plasma Surgical Inc., Roswell, GA, United States |
| Recall initiated | 2012-04-27 |
| Classified | 2012-06-11 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2012-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 36 units |
| Reason classes | packaging |
| Lot numbers | 40041, 40043 |
| Expiration dates | 2015-02-20 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1794-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.