Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall AggreGuide A-100 Instrument The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusCompletedWhereNo state named
- Medical device recall VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software… There are 7 reported software anomalies that may affect use of the device. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall T-SPOT.TB REF TB.300 US Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Georgia, Indiana, Oregon and Washington
- Medical device recall T-Cell Xtend Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Georgia, Indiana, Oregon and Washington
- Medical device recall AIM-V Medium Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, California, District of Columbia, Georgia, Indiana, Oregon and Washington
- Medical device recall EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Artis Q floor Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis pheno Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Artis icono biplane Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dimension Vista LOCI CA 15-3 Flex reagent cartridge Negative bias with patient samples. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereArizona, Georgia, Illinois, Montana, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall therascreen FGFR RGQ RT-PCR kit (US IVD) Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereIndiana, Minnesota, North Carolina and Texas
- Medical device recall therascreen FGFR RGQ RT-PCR Kit (CE IVD, not Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereIndiana, Minnesota, North Carolina and Texas
- Medical device recall FGFR RGQ RT-PCR Kit (RUO, not IVD) Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereIndiana, Minnesota, North Carolina and Texas
- Medical device recall ARCHITECT STAT Troponin-I Reagent Kit One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFX-8000V. For radiographic and fluoroscopic studies and intervention. The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use Some of the devices did not pass fatigue testing. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedSep 7, 2022ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Procedure packs contained a recalled product. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 7, 2022ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Tennessee named
- Medical device recall The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System… There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston… There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston… There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Pentacam AXL Wave Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Pentacam AXL Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Pentacam HR REF 70900. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs Class IIFDA’s classSep 7, 2022in FDA’s Enforcement Report37 statesnamed in where it went PublishedSep 7, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile Higher than expected flow rate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2022in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 31, 2022ClassClass IStatusTerminatedWhereAlabama, California, Illinois, Kentucky, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall HAMILTON-C6 Intensive Care Ventilator Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2022ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall EVIS EXERA III Bronchovideoscope The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 31, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, North Carolina, Pennsylvania and Texas named
- Medical device recall Maquet Critical Care AB/Getinge Servo-u Ventilator System Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 31, 2022ClassClass IStatusOngoingWhereNationwide, and Georgia and Puerto Rico named
- Medical device recall NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG) Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2022in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 31, 2022ClassClass IStatusTerminatedWhereAlabama, Colorado, Florida, Georgia, Illinois, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania and South Carolina
- Medical device recall DeRoyal limb holders The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 31, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Nevada, Rhode Island, Tennessee, Texas and West Virginia named
- Medical device recall NUCLISENS easyMAG Magnetic Silica There is a potential of no result leading to possible delayed result due to contamination of extraction reagents. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Florida, Hawaii, North Carolina, New York, Oregon, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall (1) GE Centricity Universal Viewer 6.0 Inaccurate Distance and Area measurements with use of Global Stack viewport. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00 An incorrect sizing label was applied to the carton packaging. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, New York, Pennsylvania and Tennessee named
- Medical device recall Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring… Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is… Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProPlan CMF Anatomical MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2022ClassClass IIStatusCompletedWhereNationwide, and Maryland named
- Medical device recall The Exacta-Mix 2400 compounding system There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Vanta Clinician Programmer Application Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be… Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 31, 2022ClassClass 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 Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportMarylandthe one state its words name PublishedAug 31, 2022ClassClass IIStatusCompletedWhereMaryland
- Medical device recall HANA/PROFx CLASSIC FEMORAL HOOK RIGHT One batch of “regular” femoral hooks were incorrectly etched with the “classic” femoral hook model number. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Michigan, Nebraska, New Jersey, Tennessee, Utah and Washington named
- Medical device recall Vanta Clinician Programmer Application Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable… Class IIFDA’s classAug 31, 2022in FDA’s Enforcement Report50 statesnamed in where it went PublishedAug 31, 2022ClassClass 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass 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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