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 Compact Speed Reducer, 60:1 Black Max 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 Chuck Driver 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 Keyless Driver 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 CRANI-A ATTACHMENT 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 SHORT ATTACHMENT 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 SHORT HD ATTACHMENT 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 11.0cm Long Attachment 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 10.5cm Long Attachment, Non-Tapered End 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 12.4cm Heavy Duty Long Heavy Short Attachment 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 10.5cm Long Attachment 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 Bearing Sleeve, 10CM Curved 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 Bearing Sleeve, 10CM Straight 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 Bearing Sleeve, 15CM Curved 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 Bearing Sleeve, 15CM Straight 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 Bearing Sleeve, 15CM Straight Taper 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 Bearing Sleeve, 19CM Straight Taper 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 Minimal Access Attachment 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 Minimal Access 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 Minimal Access Straight Driver 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 8.0cm Medium Attachment 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 8.0CM Heavy Duty Medium Attachment 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 16cm Minimally Invasive Attachment 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 Sagittal Saw 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 Otologic Curved Micro 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 45 degree Contra Angle Attachment 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 90 degree Contra Angle Attachment 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 Oscillating MICRO-SAW 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 11cm QD Angle Attachment 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 10.5cm QD Angle Attachment 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 14cm QD Angle Attachment 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 14cm QD Angle 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 8cm QD Angle 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 7.5cm QD Angle 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 Reciprocating MICRO SAW 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 SMALL ATTACHMENT, JACOBS CHUCK 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 SMALL ATTACHMENT, J-LATCH 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 5.0cm Short 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 5.0cm Heavy Duty Short 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 Sagittal MICRO-SAW 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 20.2cm Heavy Duty Long Heavy Short 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 Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into… Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku,… Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUIOS CL Flow Cytometer Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD… Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a… Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) FDA Class I, its most serious class Class IFDA’s class (needs attention)May 3, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedMay 3, 2017ClassClass IStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the… In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 3, 2017ClassClass IStatusOngoingWhereNationwide, and Florida, Kentucky, Missouri, New York and Tennessee named
- Medical device recall 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C When scanning with the 18L6 HD transducer on the ACUSON HELX” Evolution with Touch Control, the ultrasound system may display a triple image or an image with a… Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and… BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the… Class IIIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 3, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Illinois, New Jersey, Nevada, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas 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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