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 4” Microbore T-Port Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 8” Standard Bore Ext Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 7” High Pressure Set with Bionector Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 7” Standard Bore High Pressure Ext Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 7” Standard Bore High Pressure Ext Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall Bifurcated set with check vales and Bionectors Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 4” Trifurcated set with Bionectors and check valves Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall 6” Trifurcated set with Bionectors Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately… Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Kansas, Massachusetts and Texas named
- Medical device recall Captiva’s lumbar intervertebral fusion system Reamers (color code rings on the Reamers). It is possible for the titanium color-coded ring to detach from the Reamers. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Indiana, New York and Utah
- Medical device recall HSG Trays/HS 5F Catheter Combo HSG Trays and Catheters were mislabeled. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, Minnesota, Ohio, Virginia and Wisconsin
- Medical device recall CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, MTP CX Plate, Left The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, MTP CX Plate, Right The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 2-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 3-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 4-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 5-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 6-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Utility Plate, 7-Hole The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CROSSCHECK(R) Plating system, Y-PLATE CX The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil,… SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the… The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used… The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TS Herbst Nuts with Backing The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Specialty MiniScope Mech The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the… The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24… The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LR Telescoping Cantilever Arms The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TS Crown Component 4UR The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Upper Right Telescope Unibodies The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TS ROC Crown Component 4UR The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereKansas, Nevada and Texas
- Medical device recall CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sony Medical Monitor LMD-1951MD 19 inch Monitor has either not turned on or has lost image during clinical use. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereFlorida and North Carolina
- Medical device recall OptiMedica Catalys Precision Laser System Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a… The labeling for the Iamin family of medical devices (e.g. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively… The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report53 statesnamed in where it went PublishedApr 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self)… The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report53 statesnamed in where it went PublishedApr 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
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.