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 7, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Endotracheal Tube labeled as the following: a Potential for pilot balloon non-inflation or cuff non-deflation. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Baxter Electrocardiograph, ELI 380 -DCS21 One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereTexas
- Medical device recall MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use. Lenses may be of the incorrect power. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Iowa, Kentucky, North Carolina, New York, Ohio, Oregon and Wisconsin
- Medical device recall CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE The kit contained an expired component. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, New Jersey and New York named
- Medical device recall Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereArizona, California, Colorado, Louisiana, Ohio, Pennsylvania and Texas
- Medical device recall Invisalign Express 10 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor… Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 1, 2023ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Colorado, Florida, Kentucky, Massachusetts, New Jersey, New York, Ohio, Oklahoma and Wisconsin named
- Medical device recall Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when… Packaged in the incorrect shelf carton. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Indiana and Kentucky named
- Medical device recall Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Michigan, Ohio, Tennessee, Texas and Washington named
- Medical device recall AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Michigan, Ohio, Tennessee, Texas and Washington named
- Medical device recall biokitHSV-2 Rapid Test HSV-2 rapid test may report false positive results. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 1, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, North Carolina, New York and Virginia named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000 A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor Mechanical connection between the tabletop and table base may be lost. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MobiCT-32 AIRO Mobile CT Scanner Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity Reaction Vessels Reaction vessels may contain a potential contaminant that could affect their optical performance. Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 25, 2023ClassClass IIIStatusOngoingWhereIllinois, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Oklahoma, South Carolina, Texas and West Virginia
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 7 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 7 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 7 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 mm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 10 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 19 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 15 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 24 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 28 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Jackson-Pratt Channel Drain, 32 Fr Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hemopro 2 with Vasoshield Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vasoshield Syringe Packs Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RELAY PRO, THORACIC STENT-GRAFT SYSTEM The product may be shorter than packaging indicates Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RELAY PRO, THORACIC STENT-GRAFT SYSTEM The product may be shorter than packaging indicates Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 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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