Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster

FDA Recall Z-0783-06 · Posted 2006-04-19

Recalling FirmMegadyne Medical Products, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-04-06
Date Terminated2006-08-03
Product Quantity7,523 units

Reason for Recall

Surgical device packaging may be damaged and may compromise sterility.

Firm Action

Consignees were notified by letter on 04/06/2006.

Root Cause

Other

Distribution Pattern

Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965054PENCILMegadyne Medical Products, Inc. · 1997-01-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑