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 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella 2.5 intravascular micro axial blood pump, Product Number 005042 There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella 5.0 intravascular micro axial blood pump, Product Number 005062 There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella LD intravascular micro axial blood pump, Product Number 005082 There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100 There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella CP intravascular micro axial blood pump, Product Number 0048-0032 There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045,… There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR)… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter DxA Automation System, DxA 5000 A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereAlabama, California, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin and West Virginia
- Medical device recall Beckman Coulter DxA Automation System, DxA 5000 Fit A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement Report19 statesnamed in where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereAlabama, California, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin and West Virginia
- Medical device recall Aesculap Surgical Needle, straight, 3 1/2” Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide, and District of Columbia, Missouri, Pennsylvania and Texas named
- Medical device recall NovaPlus Infant Heel Warmer, Instant Squeeze Activation Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aeris Balloon Dilation Catheter Devices were mislabeled. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia, New York and Pennsylvania named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) IABP may lose the ability to charge batteries in one or both bay slots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) IABP may lose the ability to charge batteries in one or both bay slots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Simplexa Direct Amplification Disc Kit There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Medline Probe Cover Kits Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION… Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 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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