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 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is… RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is… RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is… RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is… RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result… Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall LITe Decompression Snake Arm Product arm was manufactured with the incorrect clamp component. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereMaryland, Michigan, New Mexico and Texas
- Medical device recall Panorama 1.0T HFO, Magnetic Resonance (MR) System Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 20, 2023in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 20, 2023ClassClass IStatusOngoingWhereAlabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX Incorrect product labeling. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche… Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SagiPlan 2.2, CE0344 Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportMarylandthe one state its words name PublishedDec 20, 2023ClassClass IIStatusOngoingWhereMaryland
- Medical device recall Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens… Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of… Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and… Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic SynchroMed The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall ARTIS icono (ceiling configuration), Fluoroscopic x-ray system Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, Pennsylvania and Texas named
- Medical device recall PHYSICA HPS Tibial Liner #6 H10 Due to incorrect product labeling Class IIFDA’s classDec 20, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereArizona, California, Illinois, Louisiana and New York
- Medical device recall STERILE PVP SOLUTION The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall STERILE PVP SLN KIT The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall STERILE STERILE PREP STICK The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall STERILE PVP, REF DYNDA1649 The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall PVP SOLUTION SING STRL The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall STERILE BETADINE The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall STERILE POVIDONE The product description on the labeling includes the word “Sterile” or STRL”, however the contents of the solution inside the foil sachet is non-sterile. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Iowa, Louisiana, Massachusetts, New York and Pennsylvania named
- Medical device recall RSP Glenoid Baseplate, 30mm P2 Porous Coated Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver Class IIFDA’s classDec 20, 2023in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereArizona, California, Florida, Indiana, Kansas, Kentucky, Maine, Minnesota, Mississippi, New Jersey, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Medline Leg bag Undeclared latex Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Leg bag Undeclared latex Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Leg bag Undeclared latex Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VITROS 3600 Immunodiagnostic System During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems,… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS 4600 Chemistry System During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems,… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS 5600 Integrated System During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems,… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 3400 Chemistry System During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems,… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS XT 7600 Integrated System During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems,… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CereLink ICP Extension Cable (Extension Cable) Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedDec 20, 2023ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The System is designed as a modular system with components that include an Overhead Tube Suspension with… GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The System is designed as a modular system with components that include an Overhead Tube Suspension with… GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sensica Urine Output System BD (C.R. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump… Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the… Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Navik 3D v2, REF NAVIK3D, 3D Mapping System IFU update Class IIIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 20, 2023ClassClass IIIStatusCompletedWhereNationwide, and Wisconsin named
- Medical device recall TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification. Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Ohio, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall CARDIOHELP Emergency Drive Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 13, 2023ClassClass IStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, Ohio, South Carolina and Virginia named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ProCuity bed series Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2023ClassClass 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.