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 Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 9, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 9, 2021ClassClass IStatusCompletedWhereFlorida, Georgia, Illinois, New York and Puerto Rico
- Medical device recall Alaris Infusion Pump Module Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 9, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 9, 2021ClassClass IStatusOngoingWhereIndiana and Texas
- Medical device recall Multitom RAX with software version VF10 Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 9, 2021ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Critical Care Ventilator Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Mississippi, New York, Pennsylvania, Texas and Washington named
- Medical device recall Critical Care Ventilator Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Mississippi, New York, Pennsylvania, Texas and Washington named
- Medical device recall Critical Care Ventilator Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Mississippi, New York, Pennsylvania, Texas and Washington named
- Medical device recall Critical Care Ventilator Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, Mississippi, New York, Pennsylvania, Texas and Washington named
- Medical device recall Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support… Product mislabeled, with the incorrect product inside the package. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named
- Medical device recall Cascadia AN Interbody Convex 10x22x14mm Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Michigan, New Jersey, Pennsylvania and Utah named
- Medical device recall Cascadia AN Interbody Convex 10x22x15mm Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Michigan, New Jersey, Pennsylvania and Utah named
- Medical device recall Cascadia AN Interbody Convex 10x28x14mm Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Michigan, New Jersey, Pennsylvania and Utah named
- Medical device recall T25 Cannulated Screwdrivers (CSD 025) Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from… Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Florida, Georgia, Illinois, Indiana, North Carolina, Pennsylvania and Virginia named
- Medical device recall NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusOngoingWhereColorado, North Carolina, South Carolina and Texas
- Medical device recall 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD 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 CEMENT DELIVERY CANNULA, INTVM-CDC 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 Drill, 10 Gauge 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 Direct Access Beveled Tip Trocar, 10 Gauge 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 Direct Access Diamond Tip Trocar, 10 Gauge 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, Bipedicular Cement Delivery Cannula Kit, 10 Gauge 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 Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK 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, Direct Bipedicular, Bone Access Kit with Coxaial 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 ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge 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 Unipedicular Cement Delivery Cannula Kit, 10 Gauge 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 Bipedicular Cement Delivery Cannula, 11 Gauge 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 Direct Access Bevel Tip Trocar, 11 Gauge 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 Direct Access Diamond Tip Trocar, 11 Gauge 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 Direct Bipedicular Bone Access Kit with Drill, 11 Gauge 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(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd 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 - ACCESS, CODE INTVM-DSBAK 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 ACCESS DIAMOND TIP, CODE: INTVM-DWCd 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 SINGLE - DELIVERY 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 CEMENT DELIVERY CANNULA, CODE: INTVM-CDC 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 WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD 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, CODE: INTVM-SCDK 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 Unipedicular Cement Delivery Cannula Kit, 10 Gauge 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 Biopsy Device, 10 Gauge 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 Biopsy Device, 11 Gauge 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 Direct Access Bevel Tip Trocar, 11 Gauge 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 Directional Cement Cannula Long 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 Directional Cement 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 SINGLE - ACCESS, CODE: INTV-DWCb 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 Direct Access Diamond Tip Trocar, 11 Gauge 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 Direct Bipedicular Bone Access Kit with Drill, 11 Gauge 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 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC 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, CODE: INTVM-DRL 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 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
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.”
Your shortlist0 of 4
Add one more to compare.