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 Access Substrate On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229,… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter Peri-Guard Repair Patch (legacy A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereConnecticut, Illinois, Pennsylvania, Texas and Virginia
- Medical device recall Baxter Supple Peri-Guard Repair Patch (legacy A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereConnecticut, Illinois, Pennsylvania, Texas and Virginia
- Medical device recall Baxter Peri-Guard Repair Patch (new A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereConnecticut, Illinois, Pennsylvania, Texas and Virginia
- Medical device recall Baxter Supple Peri-Guard Repair Patch (new A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereConnecticut, Illinois, Pennsylvania, Texas and Virginia
- Medical device recall Medivance Neonatal ArcticGel Pads Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GeoMed Custom Tracecarts DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 3, 2024ClassClass IStatusOngoingWhereFlorida
- Medical device recall RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient… The stent-graft inside the delivery system was the incorrect size. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 3, 2024ClassClass IIStatusCompletedWhereNationwide, and Arizona, Massachusetts and Texas named
- Medical device recall SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Patient Information Center iX (PIC iX) It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareEvent Event Management System It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Epix Universal Clip Applier Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedApr 3, 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 Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Epix Universal Clip Applier Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedApr 3, 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 Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Boston Scientific iSLEEVE EXPANDABLE Introducer Set Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HydroFlock Sterile Flocked Collection Device It was discovered through a customer complaint that mislabeled product was distributed. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Virginia named
- Medical device recall IV Start Kit, containing 1 Saline Syringe 5ml The kits contain saline flush syringes which were recalled by the supplier. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Minnesota and North Dakota named
- Medical device recall O.T.D - Optimum Traction Device - Street Orange Failure of adhesive to secure the pole insert. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall OptiCross Coronary Imaging Catheter Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter) Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall HeartMate II Left Ventricular Assist System (LVAS): 1 Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 27, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall HeartMate 3 Left Ventricular Assist System (LVAS): 1 Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 27, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Access Total T4 Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall DCA Systems HbA1c Reagent Kit The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TENSIVE Conductive Adhesive Gel Natus has become aware that its third-party supplier Parker Laboratories Inc. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers Natus has become aware that its third-party supplier Parker Laboratories Inc. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in… Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway… Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to… May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to… May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Pennsylvania and Texas named
- Medical device recall Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult” Pregnancy (hCG)… Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Pennsylvania and Texas named
- Medical device recall Steris Corporation Endo Cleaning Indicator VERIFY” RESITEST” Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Pennsylvania and Texas named
- Medical device recall Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Pennsylvania and Texas named
- Medical device recall Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Pennsylvania and Texas named
- Medical device recall Medtronic DLP Vessel Cannula Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090 There is a potential for sterile package breach. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Assembly, Array Guide TMINI There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Missouri, Nevada, Ohio, Texas and Utah named
- Medical device recall I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Preat Nobel Active/Conical-compatible RP Titanium Blank Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Ohio and Pennsylvania named
- Medical device recall impression coping, repositionable, short, screw-retained, PF 4.0 The depth of the internal canal was not manufactured according to specifications. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Kentucky and Ohio named
- Medical device recall Liquid Protein Calibrators The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. Class IIFDA’s classMar 27, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Maine, New Jersey, Ohio and Oregon
- Medical device recall HDS Traction Boot II Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Situate Laparotomy Sponge, RF and X-ray Detectable Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Directional Laser Probe with Alcon / Lumenis connector When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the… Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, Puerto Rico, South Carolina and Texas 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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