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Biopsybell S.R.L. FDA Recalls

19 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15Class IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-USClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCBClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCBClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CCClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCDClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAKClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-USClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111Class IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051Class IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDKClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBDClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAKClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing systemClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10 GAUGE DRILL, CODE INTVM-DRLClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDCClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDKClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DSClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMSClass IIMar 22, 2021Products labeled as sterile were distributed, but may not ha	Products labeled as sterile were distributed, but may not have been sterilized.	Class IIDevices	Mar 22, 2021

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