# FDA recall Z-1941-2018

> **Olsen Medical** · Class II · device recall initiated 2018-05-11.

## 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.

## Reason for recall

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

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1941-2018
- **Recalling firm:** Olsen Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-11
- **Report date:** 2018-06-06
- **Termination date:** 2019-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2018

## Citation

> AI Analytics. FDA recall Z-1941-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1941-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*