Biopsybell 8G Direct Working Cannula Bevel Tip Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
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 involves a medical device labeled as sterile but potentially not sterilized, which poses a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips, code INTV-DWCB, lot 30061432. The recall involves 30 units that were distributed in the United States, specifically in the states of Mississippi and Kentucky.
The recall was initiated because the products were labeled as sterile but may not have been sterilized. This defect poses a risk of infection if the devices are used in medical procedures.
Healthcare providers and patients who have these specific devices should stop using them immediately. Users should contact Biopsybell S.R.L. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 30
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: 30061432
Distribution
Part of a larger recall action
This product is one of 19 recalled by BIOPSYBELL S.R.L. 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 19 products in this recall →Related recalls
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