Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Button Switchpens Recalled by PSC Industries Inc Due to The Tyvek pouch label for this device states:...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PSC Industries Inc directly.
Affected Products
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Quantity: 725 units (125=Lot #023392 & 600 units Lot #022438)
Why Was This Recalled?
The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PSC Industries Inc
PSC Industries Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report