Olsen Medical: Medical Device Recall in 2018 - (Recall #: Z-1941-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-1941-2018

Event ID: 80080

Reason for Recall:

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Status: Terminated

Product Quantity: 665,350 devices

Code Information:

all codes

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated