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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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