Biopsybell 10 Gauge Drill Recalled for Potential Sterility Failure
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills labeled as sterile that 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 classification is Class II, and the hazard involves a medical device that may not be sterile, posing a significant risk of infection or serious injury.
Plain-English summary
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills, code INTVM-DRL, lot 20102486. The recall is due to the possibility that the products were distributed labeled as sterile but may not have been sterilized.
The affected products were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky. No specific dates of distribution or additional distribution details are provided in the source text.
Consumers and healthcare facilities should stop using the affected 10 Gauge Drills immediately. Users should contact Biopsybell S.R.L. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 10 GAUGE DRILL, CODE INTVM-DRL
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 75
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: 20102486
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
- High10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure
FDA (Devices) · 2021-06-09
- HighZavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighZVplasty Drill units may not have been adequately sterilized
FDA (Devices) · 2021-06-09
- ModerateMedtronic Recalls Sterile Drill Bits Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighSynthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility
FDA (Devices) · 2024-03-13
- HighSemi-automatic Biopsy Needles Recalled Due to Sterilization Defect
FDA (Devices) · 2021-08-04