Olsen Medical Recalls Symmetry Monopolar Pencil Devices Due to Seal Risk
Olsen Medical is recalling 665,350 Symmetry Monopolar Pencil devices because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential compromise of the sterile seal, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity score.
Plain-English summary
Olsen Medical is recalling 665,350 units of the Symmetry Olsen Monopolar Pencil. The affected products include various configurations of Button Switchpen, Rocker Switchpen, and Foot Controlled Handle devices with standard or extendable needle and blade electrodes. The devices are designed to hold active electrodes.
The recall was initiated because the products may encroach into the sterile pouch seal, thereby increasing the risk of the seal being compromised. This defect could potentially affect the sterility of the devices.
The recalled devices were distributed worldwide. Consumers and healthcare providers should stop using these devices and contact Olsen Medical for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- Olsen Medical
- Hazard
- Affected units
- 665,350
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Olsen Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Olsen Medical
See all →- HighOlsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
- ModerateOlsen Medical Recalls Bipolar Cords Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
- ModerateOlsen Medical Recalls Symmetry Monopolar Cords Due to Seal Risk
FDA (Devices) · 2018-06-06
- ModerateOlsen Medical Recalls Bipolar Forceps Due to Sterile Seal Risk
FDA (Devices) · 2018-06-06
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12