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 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Shandon Rapid Chrome Kwik-Diff Kit Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement Report24 statesnamed in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Delaware, Georgia, Hawaii, Iowa, Illinois, Kansas, Massachusetts, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall SurFlo IV Catheter According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD FlowSmart Set MiniMed Pro-set Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage:… A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMay 10, 2017ClassClass 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, 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, Wisconsin and West Virginia named
- Medical device recall MR GHIATAS Beaded Breast Localization Wire It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Missouri, North Carolina, New Jersey, New Mexico, New York, Oklahoma, Texas, Washington and Wisconsin named
- Medical device recall Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an… They may not have been sealed prior to sterilization. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10 The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12 The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14 The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16 The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM The stability data does not support the product labeled with a 10-year shelf life. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single… When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular… Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement Report24 statesnamed in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Michigan, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge The units may display the alarm “sampling line clogged” after the flow zeroing procedure that is conducted automatically 1 hour after start up. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereAlabama, Florida, Idaho, Louisiana, Missouri, North Carolina, Oklahoma, South Carolina, Texas and Utah
- Medical device recall Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270… ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient’s face. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder… ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient’s face. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable A damaged temperature sensor at the endoscope’s tip can cause the endoscope’s distal end to become abnormally hot. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 14cm QD Angle Attachment Product Usage: Product attachment Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Foot control irrigation system Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Autolube-III Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Autolube-III with 20ft hose Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall AL-III-DISS Adapter Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Autolube-III with Foot Guard Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Autolube-III with Irrigation Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Autolube-III with NK Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 19cm Attachment, Black Max Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall IMRI AIR CONTROL Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall IMRI MOTOR Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico 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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