Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-05-10FDA-DeviceSysmex America IncClass IISysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
- 2017-05-10FDA-DeviceTerumo Medical CorporationClass IIDestination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
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 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II20.2cm Heavy Duty Long Heavy Short Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IISagittal MICRO-SAW
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II5.0cm Heavy Duty Short Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II5.0cm Short Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IISMALL ATTACHMENT, J-LATCH
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IISMALL ATTACHMENT, JACOBS CHUCK
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIReciprocating MICRO SAW
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II7.5cm QD Angle Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II8cm QD Angle Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II14cm QD Angle Attachment
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II14cm QD Angle Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II10.5cm QD Angle Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II11cm QD Angle Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIOscillating MICRO-SAW Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II90 degree Contra Angle Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II45 degree Contra Angle Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIOtologic Curved Micro Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IISagittal Saw Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II16cm Minimally Invasive Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class II8.0cm Medium Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIMinimal Access Straight Driver Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIMinimal Access Attachment, BLACK MAX Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIMinimal Access Attachment Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIBearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIBearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIBearing Sleeve, 15CM Straight Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- 2017-05-10FDA-DeviceThe Anspach Effort, Inc.Class IIBearing Sleeve, 15CM Curved Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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