Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg Screw is 16mm long instead of 22mm long. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours)… Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Airvo 2 Humidifier Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result… Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Syntel Silicone Thrombectomy Catheter, Sterile The guide tip can become damaged and result in the tip detaching. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring… An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, New York and Texas named
- Medical device recall The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring… An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, New York and Texas named
- Medical device recall Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. Event Catalog information does not save when copied and transferred from one unit to another. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Florida, Georgia, Iowa, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and West Virginia named
- Medical device recall Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD A packaging seal gap could impact the sterility of the product. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Iowa, Indiana, Minnesota, North Carolina, Ohio, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems… Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or… Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Mississippi and New Hampshire named
- Medical device recall Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems… Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or… Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Mississippi and New Hampshire named
- Medical device recall CARDIOHELP-i System The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and New Jersey and Texas named
- Medical device recall EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Devices may contain elevated levels of bacterial endotoxin. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Devices may contain elevated levels of bacterial endotoxin. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose,… The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Indiana, Nevada and Texas named
- Medical device recall CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. Potential contamination of the product with latex adhesive residual. Class IIFDA’s classMay 22, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm Potential of the nozzle separating during patient use. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1)… Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort,… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500… Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4)… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, North Carolina, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall PERLA TL 25D SCREW Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California and Kentucky named
- Medical device recall Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum… Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 24CM STR Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 24CM STR Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 28CM STR Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 28CM STR Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 32CM STR Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular… XXX Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular… Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMay 15, 2024ClassClass IIStatusOngoingWhereVirginia
- Medical device recall Baxter Spectrum IQ Infusion Pump One device was improperly performed testing prior to release from a Service Center. Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Stealth S8 Clinical Software Application Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the “distance to target” or “tip stop point” display during… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Innova IGS 5, computed tomography x-ray system GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Massachusetts, North Carolina, Oklahoma, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Intelli-C: Right side suspended Tabletop X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT… Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide, and Hawaii, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nevada, New York, Ohio, Pennsylvania, South Carolina, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation… Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure Class IIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug… Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Class IIIFDA’s classMay 15, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2024ClassClass IIIStatusOngoingWhereNationwide
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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