Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns
Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
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 and involves a medical device that may not be sterile, posing a significant risk of infection or serious injury to patients.
Plain-English summary
Biopsybell S.R.L. is recalling 30 units of 8G Direct Working Cannula Bevel Tip, Code INTVM-DWCB, Lot 20061432. The recall was initiated because the products were 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. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the affected cannula tips immediately. Users should contact Biopsybell S.R.L. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 30
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: 20061432
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 Direct Working Cannula Recalled for Sterilization Defect
FDA (Devices) · 2021-06-09
- SevereLivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach
FDA (Devices) · 2020-07-08
- ModerateIntuitive Surgical Recalls 8mm Cannulas for Labeling Clarification
FDA (Devices) · 2013-06-05
- HighZavation Coaxial Cannula Lot 20102495 Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighNuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk
FDA (Devices) · 2012-11-28
- HighVitreq Recalls VitreQ 23G Silicone Tipped Cannula Due to Sterility Concerns
FDA (Devices) · 2020-02-05