Reported Jun 6, 2018 · Terminated
Symmetry Olsen Monopolar Pencil
Olsen Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olsen Medical · 3230 Commerce Center Pl · Louisville, KY · 40211-1900
Is this the product you have?
Symmetry Olsen Monopolar Pencil
7 of 7 products
| Model / number | Product as published |
|---|---|
75505 | QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode |
75530 | QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode |
75610 | QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure |
75800 | QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure |
75810 | QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure |
75820 | QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode |
95012 | QTY 100 Designed to hold active electrodes. |
- Lot codes and dates
- all codes
- Amount recalled
- 665,350 devices
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Olsen Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.