Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns
Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving a medical device that may not be sterile, which poses a risk of infection and potential hospitalization, fitting the 'Severe' criteria for significant injury risk.
Plain-English summary
Biopsybell S.R.L. is recalling 75 units of the 11G Direct Working Cannula Diamond Tip Mini, code INTVMN-DWCD, lot 2002437. The recall is being conducted because the products were labeled as sterile but may not have been sterilized.
The affected units were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky. The FDA has classified this recall as Class II.
Healthcare providers and consumers should stop using these specific cannulas and contact Biopsybell S.R.L. for instructions on return or replacement.
The recalled product
- Product
- 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 75
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: 2002437
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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