Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall VersaSafe Plastic Cannula - 11 Gauge Punctures in blister packaging that was detected during the packaging process. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereColorado, Illinois, Indiana, Maryland, Michigan, New York, Ohio and Texas
- Medical device recall Plum 360 Infusion System Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm… Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Dryer unit not heating. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Dryer unit not heating. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Dryer unit not heating. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the… LeadCare II Test Kits controls out of range Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EMBLEM S-ICD The device can deliver an atypical amount of energy due to memory corruption inside the device. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall EMBLEM MRI S-ICD The device can deliver an atypical amount of energy due to memory corruption inside the device. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall SQ-RX 1010 Pulse Generator, Rx The device can deliver an atypical amount of energy due to memory corruption inside the device. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall HomeChoice Automated PD system Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp… Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HomeChoice Pro Automated PD system Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp… Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive… Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 23, 2017ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Encore(TM) 26 Inflation Device Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha” Thoracic Endovascular Graft is indicated for the… There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Syringe Bulb, 60 CC 50 pcs per case Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/case The products… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case, 3,000/case The products… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington 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.”
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