Biopsybell 10G Direct Single Access Devices Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 330 units of 10G Direct Single Access devices 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 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 harm (infection) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biopsybell S.R.L. is recalling 330 units of 10G Direct Single - Access devices, identified by the code INTVM-DSBAK. The recall affects specific lots: 2001201, 2003859, 20051288, and 20061419.
The reason for the recall is that the products were labeled as sterile but may not have been sterilized. This potential lack of sterilization poses a risk of infection if the devices are used as intended.
The devices were distributed nationwide in the United States, specifically in the states of Mississippi (MS) and Kentucky (KY). Healthcare facilities and consumers who have these specific lots should stop using the devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 330
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: 2001201
- 2003859
- 20051288
- 20061419
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
Same manufacturer · BIOPSYBELL S.R.L.
See all →- HighBiopsybell 8G Direct Working Cannula Bevel Tip Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26
- HighBPB medica Osteobell Explant Needle Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26
- SevereBiopsybell CEMIX Cement Mixing System Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26
- SevereBiopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26
- HighBiopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns
FDA (Devices) · 2021-05-26
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighOrthopedic spinal surgical device may lack adequate sterilization
FDA (Devices) · 2021-06-09
- HighOrthopedic spinal surgical device recalled for inadequate sterilization
FDA (Devices) · 2021-06-09
- High10G Direct Single Bone Access Kits recalled for sterilization failure
FDA (Devices) · 2021-06-09
- HighZavation Spinal Stylet Instruments Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighMedtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
FDA (Devices) · 2014-11-26
- HighMedtronic Recalls Instrument Trackers Due to Sterility Control Issues
FDA (Devices) · 2014-11-26