Symmetry Olsen Monopolar Pencil: — Class II medical device recall Z-1941-2018
Terminated recall by Olsen Medical, reported 2018-06-06. Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
| Recall number | Z-1941-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olsen Medical, Louisville, KY, United States |
| Recall initiated | 2018-05-11 |
| Classified | 2018-05-25 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-04-15 |
| Quantity | 665,350 devices |
| Reason classes | sterility, packaging |
| Model numbers | 100, 75505, 75530, 75610, 75800, 75810, 75820, 95012 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1941-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.