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 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medical device recall REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min There is the potential that the safety shield may not properly engage on IV catheters. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Massachusetts, Minnesota, Missouri, Mississippi, New Jersey, Ohio and Texas named
- Medical device recall Bard Marquee Disposable Core Biopsy Instrument Kit Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Indiana, Louisiana, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Puerto Rico, Tennessee, Texas and Washington named
- Medical device recall Meera Mobile Operating Table-to support and position the patient immediately before, during and after… Under certain conditions, an issue might prevent the device from performing as intended. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall API3200MD Mass Spectrometer In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 4500MD Triple Quad Mass Spectrometer In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Citrine QTRAP Mass Spectrometer In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Citrine Triple Quad Mass Spectrometer In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus)… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Dermatome Blades- 10-pack boxes of blades Skin grafts thin and non-uniform when using the affected blades. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GS0008 2Y - Burn Pack - STL Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 11, 2023ClassClass IIStatusOngoingWhereMissouri
- Medical device recall LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series,… The stopper block on the LFS bracket could be broken or missing. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportMichiganthe one state its words name PublishedOct 11, 2023ClassClass IIStatusOngoingWhereMichigan
- Medical device recall LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3… The stopper block on the LFS bracket could be broken or missing. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportMichiganthe one state its words name PublishedOct 11, 2023ClassClass IIStatusOngoingWhereMichigan
- Medical device recall Incisive CT, software version 5.0 Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max,… In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case. The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures… Updated User Manual DSR3200000 Rev. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Puritan Bennett Cuff Pressure Manager Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Illinois, Kansas, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New York, Tennessee, Texas and Utah
- Medical device recall Venue Go Standard Carts Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids… 19-gauge x 1” inch filter needles showed appearances of a small fraction of non-preferred characteristics. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow… A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Massachusetts and Michigan named
- Medical device recall EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo… A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Massachusetts and Michigan named
- Medical device recall F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Restore Clinician Programmer Application Software The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Heartmate 3 LVAS Implant Kit Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System,… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin and West Virginia named
- Medical device recall Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)”… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT… Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation… Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall therascreen ¿KRAS RGQ PCR Kit Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Illinois, Indiana, Kansas, Massachusetts, North Carolina, New York, Oregon, Pennsylvania, Tennessee and Texas named
- Medical device recall ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu… Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and… The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Respironics V60/V60 Plus Ventilator, PCBA Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 4, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 4, 2023ClassClass IStatusOngoingWhereCalifornia, Ohio, Oregon and South Carolina
- Medical device recall Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of… A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood… Various medical devices potentially exposed to rodent and rodent activity. Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide, and New Jersey and Wisconsin named
- Medical device recall ProSun International Luxura Vegaz In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit. Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Attest Super Rapid Readout Biological Indicator Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest… Class IIFDA’s classOct 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 4, 2023ClassClass IIStatusOngoingWhereNationwide
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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