Device recall

Z-1941-2018: Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle…

FDA device recall · Class II · Olsen Medical

Key facts

Recall number (Z-number) Z-1941-2018
Recall event 80080
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…
Product code GEI
Recalling firm Olsen Medical
Recall class Class II
Status Terminated
Termination date Apr 15, 2019
510(k) numbers K936304
FEI number 3000719969

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)