Biopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns
Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 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 that may not be sterile, posing a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biopsybell S.R.L. is recalling 50 units of 10G Direct Working Cannula Bevel Tip 15CM, code INTVM-DWCB/15, lot 20071561. The products 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.
Consumers and healthcare facilities should stop using these products immediately and contact Biopsybell S.R.L. for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 50
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: 20071561
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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