Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure
Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits 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 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biopsybell S.R.L. is recalling 305 units of 10 Gauge Single Cement Delivery 4 Fillers 4 Syringes, code INTVM-SCDK. The recall was initiated because the products were labeled as sterile but may not have been sterilized.
The affected lots are 2002439, 20051290, 20061420, and 20081943. 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.
The recalled product
- Product
- 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 305
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 (4)
- LOT: 2002439
- 20051290
- 20061420
- 20081943
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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