Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns
Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as infection from non-sterile medical devices) are rated as Severe (4).
Plain-English summary
Biopsybell S.R.L. is recalling 160 units of 11G Direct Single - Delivery (4 Fillers-4 Syringes), code INTVMN-SCDK. The recall is due to a potential sterility issue where the products were labeled as sterile but may not have been sterilized.
The affected lots are 2001185, 2001243, and 20051163. These products were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky.
Healthcare providers and consumers should stop using these products immediately and contact Biopsybell S.R.L. for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 160
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 (3)
- LOT: 2001185
- 2001243
- 20051163
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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