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Biopsybell S.R.L.

Country not established FDA

Devices
2
Registrations
FDA
FDA recalls
19

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Biopsybell S.R.L. makes

Biopsybell S.R.L. manufactures bone marrow biopsy tools, including manual, semi-automatic, and automatic biopsy needles in various gauges and lengths. Their product line also includes complete biopsy sets, trays, and kits designed for sterile collection and processing of marrow samples. These devices are intended for clinical use in procedures requiring precise tissue extraction.

The company’s devices fall under Class II regulatory classification and are listed via FDA 510(k) clearance. Their portfolio is regulated under US medical device standards, and the manufacturer is based in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls19

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 19
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 19 recalls.

  • 2021

    • 22 Mar 2021 Z-1631-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1632-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1633-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1634-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY. Submission number: K130616
    • 22 Mar 2021 Z-1635-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1636-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1637-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1638-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1639-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1640-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
Show all 19 recalls

  • 2021

    • 22 Mar 2021 Z-1641-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1642-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1643-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1644-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1645-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1646-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1647-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1648-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.
    • 22 Mar 2021 Z-1649-2021 Class II Terminated Products labeled as sterile were distributed, but may not have been sterilized.via FDA establishment BIOPSYBELL S.R.L. Distribution: US Nationwide distribution in the states MS and KY.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Biopsybell S.R.L. MIRANDOLA Modena · IT FEI 3003272754

Frequently asked questions

How many devices does Biopsybell S.R.L. have in the registry?

The registry currently lists 2 devices for Biopsybell S.R.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biopsybell S.R.L.'s devices?

Among its 2 most recently registered devices, Biopsybell S.R.L. has devices listed in FDA 510(k) (2 devices).

What risk classes do Biopsybell S.R.L.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Biopsybell S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Biopsybell S.R.L.?

FDA recall records list 19 recalls initiated by Biopsybell S.R.L., the most recent initiated on 2021-03-22. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Biopsybell S.R.L. in the registry?

The most recently registered devices listed for Biopsybell S.R.L. include Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm and MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES.

Which FDA establishments are linked to Biopsybell S.R.L.?

1 FDA establishment is linked to Biopsybell S.R.L. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.