The Recall Desk

Manufacturer

BIOPSYBELL S.R.L.

19 recalls in our database name BIOPSYBELL S.R.L. as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
11
Most recent
2021-05-26

Of the 19 recalls from BIOPSYBELL S.R.L. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (58%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • SevereFDA (Devices)·Z-1641-2021·2021-05-26

    Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns

    Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    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.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2021·2021-05-26

    BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

    BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

    Product
    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2021·2021-05-26

    Biopsybell Cement Mixing System Recalled for Potential Sterility Failure

    Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.

    Product
    CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2021·2021-05-26

    Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns

    Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.

    Product
    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2021·2021-05-26

    Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns

    Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2021·2021-05-26

    BPB medica Osteobell Explant Needle Recalled for Sterility Concerns

    BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.

    Product
    BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2021·2021-05-26

    Biopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns

    Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.

    Product
    10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2021·2021-05-26

    Biopsybell Easynject Device Recalled for Potential Sterility Failure

    Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.

    Product
    EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2021·2021-05-26

    Biopsybell Recalls Sterile Spine Bone Filler Due to Sterilization Concerns

    Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.

    Product
    RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2021·2021-05-26

    Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure

    Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide