Z-1991-2012Class II

Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device...

Name: Z-1991-2012 Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device...
Creator: PSC Industries Inc
Published: 2012-06-05
License: https://open.fda.gov/license/

Olsen Medical / initiated 2012-06-05 / Terminated / root cause: labeling and UDI

FDA source

PSC Industries Inc began a recall of Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800... on 2012-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1991-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-05
Posted: 2012-07-11
Terminated: 2014-01-17
Recalling firm: Olsen Medical
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Olsen Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated June 5, 2012. The letter identifies the product, problem, and actions to be taken by the customers. The letter asks that the customer immediately examine their inventory for the presence of the suspect product and quarantine the product, if found. Customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. The customers are also asked to call a toll-free telephone number in order to received a Return Material Authorization (RMA) number and so identify if they would like credit or replacement inventory upon returning the product. The customer is also asked to complete and return the enclosed 'Recall Response Form' and to fax the completed form to the fax number on the form or to send the completed from back to the recalling firm via parcel post.
Quantity in commerce: 725 units (125=Lot #023392 & 600 units Lot #022438)
Distribution: Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Product codes and lots: Model Number: 75800, Lot Numbers: 023392 and 022438

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1991-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1990-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11
Z-1991-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11

Product code GEI

K936304Class IIElectrosurgical PencilE & M Engineering, Inc. / cleared 1994-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)