Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall 10G DIRECT SINGLE BONE ACCESS KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G SINGLE CEMENT DELIVERY KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 11G BEVELED TROCAR/CANNULA Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 11G DIAMOND TROCAR/CANNULA Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G DIRECT DOUBLE BONE ACCESS KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 11G DIRECT DOUBLE BONE ACCESS KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G SINGLE CEMENT DELIVERY KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G DOUBLE CEMENT DELIVERY KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G DIRECT DOUBLE BONE ACCESS KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G DIRECT SINGLE BONE ACCESS KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 GAUGE DRILL STERILE Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G CEMENT DELIVERY CANNULA Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10G BEVELED TROCAR/CANNULA Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 10 GAUGE DIRECT UNILATERAL STYLET Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterV, 10G Kyphoplasty Kits Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterV, 10G FLEX Kyphoplasty Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterV CurvePlus Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterV 10G Bone Access Tools/Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InterV 11G Kyphoplasty Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OsteoFlex BONE CEMENT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty System, 10mm, Pat# VCF-1010-2 Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty, 10G, 10mm Double Balloon Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty System, 15mm, Part# VCF-1015-1 Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty System, 15mm, Part# VCF-1015-1 Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty 10G, 15mm, Additional Level Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty System, 15mm Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty 10G, FLEX KYPHOPLASTY Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty 10G, 15mm Single Balloon Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty 10G, 20mm, Traditional Unipedicular Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVplasty System, 20mm, Part# VCF-1020-2 Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZVPlasty, 11G, 15mm Traditional Bipedicular Kit Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OsteoFlex Cement and Mixing System Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERTEBREX SINGLE BALLOON KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERTEBREX SINGLE BALLOON KIT Products distributed as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Michigan, Minnesota, Tennessee, Texas and Washington
- Medical device recall MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020… Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Michigan, Minnesota, Tennessee, Texas and Washington
- Medical device recall Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the… A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 9, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and Wyoming named
- Medical device recall BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Nevada named
- Medical device recall Synapse Cardiovascular (Synapse CV) Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall REF 4049 MICROSS, CE0123, STERILE EO Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall REF 4890 SMARTSCRAPER CE0123, STERILE EO Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medical device recall Tranberg MR Cannula single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland and Texas named
- Medical device recall Tranberg MR Stylet, 1.8mm/15G, 230mm single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland and Texas named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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