Olsen Medical Recalls Bipolar Forceps Due to Sterile Seal Risk
Olsen Medical is recalling specific Symmetry Olsen bipolar forceps 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, 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 specific Symmetry Olsen bipolar forceps, including various models of insulated irrigating bayonet forceps, precision non-stick insulated irrigating forceps, and other surgical instruments. The recall covers 611,817 devices that were distributed worldwide.
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 instruments.
Healthcare facilities and consumers should stop using the affected devices and contact Olsen Medical for further instructions on the recall process.
The recalled product
- Product
- Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.
- Manufacturer
- Olsen Medical
- Hazard
- Affected units
- 611,817
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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