CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
Direct Working Cannula Bevel Tip recalled by Biopsybell S.r.l
Biopsybell S.r.l is recalling Direct Working Cannula Bevel Tip, distributed nationwide in the US. The recall was initiated on 22 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1645-2021
- FDA event ID
- 87696
- Recalling firm
- Biopsybell S.r.l, Mirandola, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2021
- FDA classified
- 19 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 22 Mar 2021 | Recall initiated by company | |
| 19 May 2021 | Classified by FDA | +58 days |
| 26 May 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
Where it was distributed
US Nationwide distribution in the states MS and KY.
Questions about this recall
Is Direct Working Cannula Bevel Tip recalled?
Yes. Biopsybell S.r.l recalled Direct Working Cannula Bevel Tip on 22 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1645-2021.
Why was it recalled?
Products labeled as sterile were distributed, but may not have been sterilized.
Which lots are affected?
LOT: 30061432
Where was it sold?
US Nationwide distribution in the states MS and KY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biopsybell S.r.l
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direct Working Cannula Diamond Tip Mini recalled by Biopsybell S.r.l | Biopsybell S.r.l | Sterility | Nationwide |
| Device | CLASS II | Cemix - Cement Mixing System recalled by Biopsybell S.r.l | Biopsybell S.r.l | Sterility | Nationwide |
| Device | CLASS II | Cement Delivery Cannula recalled by Biopsybell S.r.l | Biopsybell S.r.l | Sterility | Nationwide |
| Device | CLASS II | Coaxial Cannula With Tuohy Connection recalled by Biopsybell S.r.l | Biopsybell S.r.l | Sterility | Nationwide |
| Device | CLASS II | Easynject, Device for cement infusion recalled by Biopsybell S.r.l | Biopsybell S.r.l | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |