Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Perkin Elmer WIZARD2 1-detector,3”, 1000 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR… A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the… Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report50 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Infant Heel Warmer and Infant Gel Warmer Product marketed without a 510(k) Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the… The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator Vacuum pump may not perform to specification. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator Vacuum pump may not perform to specification. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator Vacuum pump may not perform to specification. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile Multiaxial screws may not meet internal requirements related to fatigue strength. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Missouri, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Bausch & Lomb SofPort Advanced Optics Aspheric Lens Haptics breaking during lens loading and insertion. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for… Haptics breaking during lens loading and insertion. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is… Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Michigan, Ohio and Oregon named
- Medical device recall Sureflex 150 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sureflex 200 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sureflex 273 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sureflex 365 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sureflex 550 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sureflex 910 Lithotripsy Fiber, 5x, Blue validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 200¿M Lithotripsy Fiber- Reusable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 365¿M Lithotripsy Fiber- Reusable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 150¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 200¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 273¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex’” Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 365¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 550¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Stripper, 910¿m, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fiber Cleaver validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1X1 Cleaving Tiles validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, StripperW/BLD, 10S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, StripperW/BLD, 10S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 12S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 12S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 14S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 14S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
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.