Olympus VC-10 Vacuum Curettage System Recalled for Incompatible Accessories
Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.
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: This is an FDA Class II recall with reported adverse events involving improper equipment fit. Although serious injuries are possible, no actual injuries or hospitalizations are documented in the source material, consistent with Score 3 for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Berkeley VC-10 Vacuum Curettage System (Model No. VC-10), manufactured by Olympus Corporation of the Americas, is being recalled. This medical device is designed for transcervical aspiration of the uterine cavity.
The FDA has classified this as a Class II recall following reported adverse events involving collection canisters that were not designed for use with the VC-10. When incompatible canisters are used, they do not fit properly with the device, creating a risk of serious injury.
The recall affects 4,184 units distributed nationwide in the United States and 191 units distributed to Canada and Japan. Olympus is updating the device's Instruction for Use to include a warning against using any accessories not explicitly listed in the IFU. Healthcare facilities and clinicians should ensure only approved accessories are used with the VC-10.
The recalled product
- Product
- Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
- 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)
- UDI-DI: 00821925010475 All units are included.
Distribution
Distributed nationwide across the United States.
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