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 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System… Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement Report42 statesnamed in where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Cepheid, Sample Collection Device, Part: 900-0370 Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 21, 2024ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereColorado, Connecticut, Iowa, Illinois, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Washington
- Medical device recall Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 21, 2024ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Kansas, Kentucky, Massachusetts, Maine, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable… Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. Class IIFDA’s classAug 21, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereCalifornia, Colorado, Massachusetts, Tennessee and Texas
- Medical device recall WAVEWRITER ALPHA Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 21, 2024ClassClass 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aurora Series, Aurora 7 lighthead The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aurora 2 Series, Aurora 7 lighthead The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aurora 3 Series, Aurora 7 lighthead The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aurora 4 Series, Aurora 7 lighthead The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Salivary Testosterone ELISA Invalid Controls. Class IIIFDA’s classAug 21, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 21, 2024ClassClass IIIStatusOngoingWhereNationwide, and California, Illinois, Minnesota, Pennsylvania, Utah and Virginia named
- Medical device recall L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural… Class IIFDA’s classAug 21, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 21, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, Texas and Washington
- Medical device recall CADD-Solis Ambulatory Infusion Pumps CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall CADD-Solis VIP ambulatory Infusion Pumps The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: “ For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall CADD-Solis VIP ambulatory Infusion Pumps The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: “ For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN… Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 14, 2024ClassClass IStatusOngoingWhereArkansas, California, Colorado, District of Columbia, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia
- Medical device recall SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1,… GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1 GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low… Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2024ClassClass IIStatusOngoingWhereNo state 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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