Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns
Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, 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 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (such as lack of sterility leading to infection) are categorized as Severe.
Plain-English summary
Biopsybell S.R.L. is recalling 50 units of 11G Direct Single - Access devices, code INTVMN-DSBAK, lot 20051162. The recall was initiated because the products were labeled as sterile but may not have been sterilized.
The affected devices were distributed nationwide in the states of Mississippi and Kentucky. The source text does not specify the exact number of units distributed in each state or the specific facilities receiving the products.
Consumers and healthcare facilities should stop using these devices and contact Biopsybell S.R.L. for further instructions. The source text does not provide specific contact details or a return address.
The recalled product
- Product
- 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
- 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: 20051162
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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