Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are rated as Severe (4).
Plain-English summary
Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets (1 X Diamond 1 X Bevel), code INTVM-DSSKBD. The recall involves specific lot numbers: 19102741, 200127, 2001246, and 2101242.
The FDA has classified this as a Class II recall because the products were labeled as sterile but may not have been sterilized. This defect poses a risk of infection if the devices are used in medical procedures.
The affected units were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky. Healthcare facilities and consumers who possess these specific lots should stop using the devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 625
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: 19102741
- 200127
- 2001246
- 2101242
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
- HighZavation Spinal Stylet Instruments Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighZavation Orthopedic Stylet Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighZavation Orthopedic Spinal Stylets Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighZavation 10 Gauge Direct Access Diamond Tip Devices Recalled for Sterilization
FDA (Devices) · 2021-06-09
- ModerateImplant Direct Interactive Healing Collar Recalled for Sterility Labeling Error
FDA (Devices) · 2018-02-14
- HighOrthopedic spinal surgical device may lack adequate sterilization
FDA (Devices) · 2021-06-09