Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Sterile custom surgical procedure packs The custom procedure packs contain light handle covers that have been recalled by another firm. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall Sterile custom surgical procedure packs The custom procedure packs contain light handle covers that have been recalled by another firm. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control… QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. Class IIIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 14, 2023ClassClass IIIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to… QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. Class IIIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 14, 2023ClassClass IIIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the… Class IIIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 14, 2023ClassClass IIIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina, South Dakota, Tennessee, Texas and Washington named
- Medical device recall BencoDental iris 5% NaF varnish, WHITE MINT The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereFlorida, Nevada and Pennsylvania
- Medical device recall Magic3 Go Intermittent Urinary Catheters, Female Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Magic3 Go Intermittent Urinary Catheters, male Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Magic3 Go Intermittent Urinary Catheters, pediatric Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HydroSil Go Intermittent Urinary Catheters Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿… Device failed to function as intended and/or failed to conform to their design specifications. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-iR, used during cardiopulmonary bypass 1. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380 EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Procedure packs The kits were damaged by water. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 7, 2023ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the… Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusCompletedWhereNationwide
- Medical device recall TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Indiana, Kentucky, Montana, New Jersey, Oregon, Pennsylvania and South Carolina named
- Medical device recall TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Indiana, Kentucky, Montana, New Jersey, Oregon, Pennsylvania and South Carolina named
- Medical device recall QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall QUADROX-iR, used during cardiopulmonary bypass Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Teleflex HORIZON Microclip Titanium Ligating Clips w/tape Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk… Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 Class IIFDA’s classJun 7, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereArkansas, Indiana, Louisiana, Oklahoma, Tennessee, Virginia and Washington
- Medical device recall Intelli-C, Right side suspended Tabletop There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Iowa, Kentucky, Louisiana, Massachusetts, North Carolina, Nevada, New York, Ohio, South Carolina and Washington named
- Medical device recall Intelli-C, Left side suspended Tabletop There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Iowa, Kentucky, Louisiana, Massachusetts, North Carolina, Nevada, New York, Ohio, South Carolina and Washington named
- Medical device recall Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented Contains the incorrect implant in the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada and Texas named
- Medical device recall Luminos Agile Max (VE10, VF10, VF11) Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminos dRF Max (VE10, VF10, VF11) Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
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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