Z-1941-2018Class II

Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b)...

Name: Z-1941-2018 Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b)...
Creator: Olsen Medical
Published: 2018-05-11
License: https://open.fda.gov/license/

Olsen Medical / initiated 2018-05-11 / Terminated / root cause: packaging

FDA source

Olsen Medical began a recall of Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF... on 2018-05-11. FDA classified it as Class II and gives the reason as "Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1941-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Posted: 2018-05-25
Terminated: 2019-04-15
Recalling firm: Olsen Medical
Product: Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products. All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect. Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.
Quantity in commerce: 665,350 devices
Distribution: Worldwide Distribution
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1942-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1943-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1944-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1945-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25

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)