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 Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog… Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Outset Tablo An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Wisconsin named
- Medical device recall Flex-Neck Catheter External Repair Kit Product that was built for design verification testing was inadvertently distributed to customers. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Maryland, Michigan, Ohio and Texas named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall thermage THERMAGE CPT SYSTEM A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportMarylandthe one state its words name PublishedApr 19, 2023ClassClass IIStatusOngoingWhereMaryland
- Medical device recall CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 Distributed sample collection kit with an unapproved instruction for use. Class IIIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 19, 2023ClassClass IIIStatusOngoingWhereNationwide, and California, Georgia, Indiana, New Jersey and Texas named
- Medical device recall Titan Touch Pump A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Pump Assembly A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch NB Infr Zero 16cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch NB Infr Zero 18cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch NB Scrot Zero 16cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch NB Scrot Zero 18cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan NB Infra Zero Ang 16cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan NB Scrotal Zero Ang 18cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch Infr Zero Ang 18cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch Infr Zero Ang 22cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch Scro Zero Ang 16cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch Scro Zero Ang 20cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan Touch Scro Zero Ang 22cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan 0-Deg Infrapubic 20 Cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan 0-Deg Scrotal 18 Cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan 0-Deg Scrotal 20 Cm XXX Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Titan 0-Deg Scrotal 22 Cm A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to… Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Colorado, Connecticut, Idaho, Maryland, Montana, Tennessee and Washington named
- Medical device recall BioPlex 2200, Anti-CCP Reagent Pack Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BioPlex 2200, Anti-CCP Calibrator Set Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Edward Lifesciences There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereAlaska, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Edward Lifesciences There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereAlaska, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall NanoKnife 5-Probe Procedure Pack 15 cm - Activation Not programmed in accordance with specification. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, New York and Ohio named
- Medical device recall Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside… Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall EMPOWR Porous Knee Patella Over Drill Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereAlabama, California, Hawaii, Indiana, Kansas, Maryland, Texas and Washington
- Medical device recall stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL) Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL) Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer,… Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio and Washington named
- Medical device recall Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36… Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio and Washington named
- Medical device recall Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12… Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio and Washington named
- Medical device recall Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2) Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio and Washington named
- Medical device recall FreeStyle Libre Reader Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall FreeStyle Libre Reader Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall FreeStyle Libre Reader Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Trilogy EV300 Portable Electric Ventilator The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Trilogy Evo Universal Portable Electric Ventilator The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small) Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium) Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin 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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