Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall ColoSense Test Kit Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Missouri named
- Medical device recall REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement Report37 statesnamed in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement Report37 statesnamed in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall ADVIA¿ 120/2120/2120i SETpoint Calibrator Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) The impacted tape was manufactured with incorrect information on the tape. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Extended Tip Applicator, 8CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Extended Tip Applicator, 15 CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Extended Tip Applicator 8CM, Box of 1. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MicroMyst Applicator, Box of 5 Lack of sterility assurance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331 Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and New Jersey, Ohio and Texas named
- Medical device recall Medline UMBILICAL TRAY W/3.5&5FR CATH There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall DxI 9000 Access Immunoassay Analyzer C11137 Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Michigan, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release… Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Iowa, Illinois, New York, Pennsylvania, Texas and Washington named
- Medical device recall LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions… Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Indiana, Michigan, Ohio and Texas named
- Medical device recall REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereColorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereColorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereColorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereColorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall Caphosol Artificial Saliva Out of specification stability test result for the Caphosol B solution from process validation lots Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Omnipod 5 Automated Insulin Delivery System, iOS Application Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Product Name [REF]: Supply Server, CCE Enterprise SW Site License During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 CDI OneView System BPM Probe Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio and Washington named
- Medical device recall BD BACTEC MGIT 960 PZA Kit BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Mississippi, New York, South Carolina, Texas and Virginia named
- Medical device recall PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Mississippi, New York, South Carolina, Texas and Virginia named
- Medical device recall Jewel Precision Reusable Rigid Sterilization Container System The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Indiana, New York and Pennsylvania named
- Medical device recall Product: Atellica CH Diluent - CONS 2 x 1.5L Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487 Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare LOGIQ F R3 Ultrasound System GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Versana Ultrasound Systems GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Jewel Precision Reusable Rigid Sterilization Container System The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 2, 2025ClassClass IIStatusOngoingWhereTennessee
- Medical device recall Spectral CT. Computed tomography X-ray system. Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient,… Class IIFDA’s classJul 2, 2025in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia
- Medical device recall Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Lago X The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ami HTX. The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH. Class IIFDA’s classJun 25, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 25, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2025ClassClass IStatusOngoingWhereNationwide
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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