Olsen Medical Recalls Symmetry Monopolar Cords Due to Seal Risk
Olsen Medical is recalling 71,890 Symmetry monopolar cords 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, and the hazard involves a potential compromise of the sterile seal without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Olsen Medical is recalling 71,890 units of Symmetry monopolar cords, including specific models with TUR connectors and Bovie to 90-degree female pins. The recall covers all codes and involves worldwide distribution.
The recall was initiated because the products may encroach into the sterile pouch seal, which increases the risk of the seal being compromised. This defect could potentially affect the sterility of the devices.
Healthcare facilities and distributors should stop using the affected monopolar cords and contact Olsen Medical for further instructions on the recall.
The recalled product
- Product
- Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10…
- Manufacturer
- Olsen Medical
- Hazard
- Affected units
- 71,890
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
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