CLASS II Device recall · Reported 26 May 2021 · FDA Enforcement Report
Single Cement Delivery 4 Fillers 4 Syringes recalled by Biopsybell S.r.l
Biopsybell is recalling Single Cement Delivery 4 Fillers 4 Syringes, Code Intvm-scdk, 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-1646-2021
- FDA event ID
- 87696
- Recalling firm
- Biopsybell, 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
- Syringes & Needles
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
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Where it was distributed
US Nationwide distribution in the states MS and KY.
Questions about this recall
Why was it recalled?
Products labeled as sterile were distributed, but may not have been sterilized.
Which lots are affected?
LOT: 2002439, 20051290, 20061420, 20081943
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 87696This product is part of a recall event; the main page for the event is Bpb medica Cemix, Product Number Kvtmixn recalled by Biopsybell S.r.l.
More recalls from Biopsybell
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direct Working Cannula Diamond Tip Mini recalled by Biopsybell S.r.l | Biopsybell | Sterility | Nationwide |
| Device | CLASS II | Cemix - Cement Mixing System recalled by Biopsybell S.r.l | Biopsybell | Sterility | Nationwide |
| Device | CLASS II | Cement Delivery Cannula recalled by Biopsybell S.r.l | Biopsybell | Sterility | Nationwide |
| Device | CLASS II | Coaxial Cannula With Tuohy Connection recalled by Biopsybell S.r.l | Biopsybell | Sterility | Nationwide |
| Device | CLASS II | Easynject, Device for cement infusion recalled by Biopsybell S.r.l | Biopsybell | Sterility | Nationwide |
Other Syringes & Needles recalls
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |