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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 Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use i... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G 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 InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthope... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal p... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For ... 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, CODE: INTVM-SCDK. For ... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. Fo... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal proce... 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 Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II Zavation
Mar 25, 2021 ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal proc... 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

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.