Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Zavation
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·178 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·36 affected·Mar 25, 2021
High RiskFDA
Zavation
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Medical Devices·335 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Medical Devices·38 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Zavation
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Medical Devices·140 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Medical Devices·24 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthope...
Medical Devices·119 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Medical Devices·98 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Medical Devices·27 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Medical Devices·15 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Medical Devices·2 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Medical Devices·162 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Medical Devices·19 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
Medical Devices·14 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Medical Devices·3 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Medical Devices·56 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)0063009...
Medical Devices·580 affected·Mar 23, 2021
High RiskFDA
Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Medical Devices·1,560 affected·Mar 23, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Medical Devices·5 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
Medical Devices·160 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
Medical Devices·50 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Medical Devices·500 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Medical Devices·60 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Medical Devices·330 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
Medical Devices·50 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
Medical Devices·625 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
Medical Devices·50 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
Medical Devices·30 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10 GAUGE DRILL, CODE INTVM-DRL
Medical Devices·75 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Medical Devices·10 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
Medical Devices·30 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Medical Devices·305 affected·Mar 22, 2021