Olympus Berkeley Disposa-Filter Recall Due to Weld Defect
Olympus is recalling Berkeley Disposa-Filters used with the VC-10 Vacuum Curettage System because an ultrasonic weld defect may cause the housing to separate.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of harm (housing separation) during a medical procedure, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling the Berkeley Disposa-Filter, a component used with the Berkeley VC-10 Vacuum Curettage System. The product is designed for the rapid transcervical aspiration of the uterine cavity. The recall involves 1,106 boxes, with 10 filters per box, distributed nationwide in the United States. The specific lot number is 494604.
The recall was initiated because the Disposa-Filter may possess an insufficient ultrasonic weld defect. This defect affects the joint that connects the two halves of the filter cartridge, which could result in the housing separating during use.
Healthcare facilities and users of the Berkeley VC-10 Vacuum Curettage System should stop using the affected filters immediately. Users should check their inventory for the specific lot number 494604 and contact Olympus Corporation of the Americas for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
- Manufacturer
- Olympus Corporation of the Americas
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)
- Lot number: 494604
Distribution
Distributed nationwide across the United States.
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