Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall ARROW PICC Set Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROW PICC Set Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arrow PICC with Chlorag+ard Technology Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VPS Rhythm ECG Accessory Pack with Johans Adapter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VPS Rhythm ECG Accessory Pack Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VPS TipTracker Stylet Accessory Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Extension Line Slide Clamps Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr.… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84”… Joerns Healthcare has identified a potential issue with some of the P.R.O. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER… Joerns Healthcare has identified a potential issue with some of the P.R.O. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartStart MRx Monitor/Defibrillator The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNorth Carolina and Ohio
- Medical device recall AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5 Some left-handed gloves contain powder. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Idaho, Kansas, Minnesota, North Carolina, Ohio, Pennsylvania and Texas
- Medical device recall LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals… An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right,… Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medical Action Industries Inc Product sterility potentially compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereColorado, Kansas, Minnesota, New York, Rhode Island, Texas and Washington
- Medical device recall nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and… An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right,… Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained… There is an error related to the relative geometry between fiber tracts in a fiber group and images. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iChem VELOCITY Automated Urine Chemistry System The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia and Iowa
- Medical device recall First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3 The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4 The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall First Step Endoscopic Cleaning Pad with 4” Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit,… The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6 The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Travel Kit, First Step EP-4 Kit The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number… The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report40 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Sorin Stockert Heater-Cooler System 3T, a) Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall smith&nephew 5o A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Indiana, Massachusetts, Michigan, North Carolina, New York and Pennsylvania
- Medical device recall smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Syringe Inlet Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AMENDIA Omega Lumbar Interbody Fusion Device Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusOngoingWhereColorado, Florida, Georgia, North Carolina and Pennsylvania
- Medical device recall Philips HeartStart FRx AED. An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips HeartStart (HS1) Onsite/Home AED An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Synthes Torque Limiting Handle The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Idaho, Illinois, Kentucky, North Carolina, Nebraska, New York, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable… Class IIFDA’s classMay 30, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Minnesota, Missouri and New Jersey
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.