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 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 There was one complaint that the sidearm of the device detached during explant of a pump. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Minnesota, New Jersey and Tennessee named
- Medical device recall VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,… Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or… Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE NON-STERILE PVP SOLUTION Affected product lots were mislabeled as “STERILE PVP SLN” when they should have been titled “NON-STERILE PVP SOLUTION, STERILE PACKAGING”. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall COULTER DxH Diluent Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine… Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing… Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Quidel Triage Cardiac Panel Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall TruSignal Adult/Pediatric Sensor There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal AllFit Sensor: a) There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Sensitive Skin Sensor There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Wrap Sensor There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Ear Sensor There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Integrated Ear Sensor with GE Connector There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Integrated Ear Sensor with Datex Connector There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Integrated Ear Sensor with Datex Connector There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TruSignal Integrated Ear Sensor with Ohmeda Connector There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 12, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 12, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall TRACKMASTER, TREADMILL TMX428 110V Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL TMX428 220V Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL TMX428CP 110V Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL TMX428CP 220V Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL GE T2100-ST1 110VV Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL GE T2100-ST2 220V Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall da Vinci Xi/X Tip-Up Fenestrated Grasper Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the… Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill… Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for… Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada and Texas named
- Medical device recall LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for… Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada and Texas named
- Medical device recall OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm… 1. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10… Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend PRS Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend 1.0 Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend 2.0 Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend MP Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend 3.0 Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend 4.0 Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SurgiMend PRS Meshed Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm,… Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 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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