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Browse Device Recalls

71 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 71 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 71 FDA device recalls.

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DateProductReasonClassFirm
Mar 25, 2021 ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-D... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spin... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic /... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orth... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use i... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use i... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DS... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For us... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For us... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthop... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spin... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spina... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthope... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in O... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Ort... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For us... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal proce... Products distributed as sterile may not have been adequately sterilized Class II Zavation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.