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 Intera 1.5T, Model No. 781195 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas named
- Medical device recall SmartPath to dStream for 1.5T An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. Class IIIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 31, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska and Texas named
- Medical device recall bkActiv Ultrasound System 2300 An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section,… When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall DiaSorin LIAISON HSV-2 Type Specific IgG DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of… Class IIFDA’s classJan 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall regard Operative LAP Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportLouisianathe one state its words name PublishedJan 24, 2024ClassClass IStatusTerminatedWhereLouisiana
- Medical device recall High Frequency Transport Phasitron Breathing Circuit Kit Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement Report21 statesnamed in where it went PublishedJan 24, 2024ClassClass IStatusOngoingWhereAlabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, Tennessee, Texas, Utah and Virginia
- Medical device recall ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 24, 2024ClassClass IStatusOngoingWhereCalifornia, Colorado, Montana, South Carolina and Washington
- Medical device recall Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 24, 2024ClassClass IStatusOngoingWhereCalifornia, Rhode Island and Texas
- Medical device recall Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Express chest drains are pre-packaged with sterile water syringes which have bene recalled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Express chest drains are pre-packaged with sterile water syringes which have bene recalled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Soltive SuperPulsed Laser System TFL Fiber Stripper The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soltive SuperPulsed Laser System TFL FIBER CLEAVER The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOLTIVE SuperPulsed Laser Fibers Affected products may potentially have a breached sterile pouch seal. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement Report27 statesnamed in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Carolina, North Dakota, Nebraska, New Jersey, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number… If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement Report28 statesnamed in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont and Washington
- Medical device recall Curaplex Field Cric Kit with ET Tube It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MINC+ Benchtop Incubator, Reference The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereCalifornia, Indiana, Louisiana, Maryland and New York
- Medical device recall Vasoview Hemopro Endoscopic Vessel Harvesting System Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vasoview Hemopro Endoscopic Vessel Harvesting System Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Spectral CT 7500, Software Version 5.0.0.X Multiple software issues that affect device functionality. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM… Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, Indiana, Michigan, Missouri and Oklahoma
- Medical device recall Ultrasound EA (Ergonomic Advantage) table versions Backrest platform stress fracture - the table is not operational in an inclined position Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultrasound EA (Ergonomic Advantage) table versions Backrest platform stress fracture - the table is not operational in an inclined position Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultrasound EA (Ergonomic Advantage) table versions Backrest platform stress fracture - the table is not operational in an inclined position Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ultrasound EA (Ergonomic Advantage) table version Backrest platform stress fracture - the table is not operational in an inclined position Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) Patient Information Center iX Push notifications may fail to send to the user under certain conditions. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and West Virginia named
- Medical device recall (1) CareEvent Push notifications may fail to send to the user under certain conditions. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington and West Virginia named
- Medical device recall VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate Tubes have missing additive/anticoagulant resulting in clotting in most cases. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Iowa, Illinois, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Virginia named
- Medical device recall FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating… If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 24, 2024ClassClass IIStatusCompletedWhereNationwide, and California, Florida, Iowa, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia named
- Medical device recall TECNIS Toric II OptiBlue IOL Models ZCW Due to intraocular lens containing an angle out of specification (OOS). Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PosiFlush Prefilled Saline Syringe with General Pump Compatibility An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18… Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INDICAID COVID-19 Rapid Antigen At-Home Test COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Medex LOGICAL CATH LAB KIT, List Number M20754 There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 6IN PRESSURE TUBING, List Number MX20617 There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R There is a manufacturing defect affecting specific rotator lots. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOLTIVE SuperPulsed Laser Fibers Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total… Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and New Hampshire named
- Medical device recall GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania and Texas named
- Medical device recall Calibration Serum Level 3 There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Calibration Serum Level 3 CAL2351 CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in… Class IIFDA’s classJan 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico 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.”
Your shortlist0 of 4
Add one more to compare.