FMS 283512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,800 adverse event reports that list this exact device (DI 10886705016938), received between Dec 28, 2017 and Sep 3, 2026 — classified as 2 injuries, 1,798 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (469 reports).

4 other recalls cover devices cleared under the same FDA submission (K041824, K954465); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,800 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593656 ↗
• MalfunctionSep 3, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591844 ↗
• MalfunctionSep 2, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570545 ↗
• MalfunctionSep 1, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546521 ↗
• MalfunctionSep 1, 2026Detachment of Device or Device Component; Power Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545667 ↗
• MalfunctionAug 13, 2026Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235110 ↗
• MalfunctionJul 31, 2026Break; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104455 ↗
• MalfunctionJul 30, 2026Electrical /Electronic Property Problem; Overheating of Device; Output Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090231 ↗
• MalfunctionJul 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059131 ↗
• MalfunctionApr 30, 2026Electrical Shorting

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE HAD A DAMAGED CABLE, CAUSING AN INTERNAL SHORT CIRCUIT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044936 ↗
• MalfunctionApr 21, 2026Electrical Shorting

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE EXPERIENCED AN ELECTRICAL SHORT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940164 ↗
• MalfunctionApr 16, 2026Overheating of Device; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC VETERINARY PROCEDURE THE MICRO TORNADO HP W HANDCONTROL DEVICE THE CONSOLE WILL BEEP BUT NOTHING HAPPENS WITH THE SHAVER. AFTER A LITTLE BIT OF TIME, THE SHAFT OF THE SHAVER BEGINS TO BECOME VERY HOT. WE THEN SWITCHED OUT THE SHAVER, AND WITH OTHER SHAVER WORKED JUST FINE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905339 ↗
• MalfunctionApr 10, 2026Device Remains Activated; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MICRO TORNADO HP W HANDCONTROL DID NOT STOP ANYMORE WITH THE BUTTON. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841841 ↗
• MalfunctionApr 6, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE HAD AN ELECTRICAL SHORT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793962 ↗
• MalfunctionApr 1, 2026Mechanical Problem; Use of Device Problem; Noise, Audible

  IT WAS REPORTED THAT THE FMS SHAVER HANDPIECE IS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757597 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SHAVER DISPLAYED ERROR CODE FC:14 AND PRODUCED A SHORT IN ITS CONSOLE WHICH CAUSED DELAYS. THERE WERE NO OTHER ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711204 ↗
• MalfunctionMar 13, 2026Break; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE WAS BLOWN INTO, RESULTING IN THE LOSS OF A DAMAGED SEAL, A PLASTIC WASHER AND A RED TRANSPARENT SEAL. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590428 ↗
• MalfunctionMar 6, 2026Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE HAD AN ELECTRICAL SHORT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536873 ↗
• MalfunctionFeb 5, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE MICRO TORNADO HP W HAND CONTROL DEVICE WAS NOT ROTATING. TRIED SAME HANDPIECE ON ANOTHER CONSOLE AND STILL NOT WORKING. TRIED A NEW HANDPIECE AND IT WORKED CORRECTLY IMMEDIATELY. THE NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273310 ↗
• MalfunctionJan 23, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE WAS SHORTING OUT THE CONSOLE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161640 ↗
• MalfunctionJan 21, 2026Mechanical Problem

  IT WAS REPORTED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE HANDPIECE WAS NOT ROTATING PROPERLY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135338 ↗
• MalfunctionJan 21, 2026Use of Device Problem; Electrical Shorting

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE HAD AN ELECTRICAL SHORT. IT WAS INITIALLY REPORTED THAT DURING A DEMONSTRATION, IT WAS DISCOVERED THAT THE DEVICE DID NOT WORK. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134070 ↗
• MalfunctionJan 15, 2026Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT THE MICRO TORNADO HP W HANDCONTROL DEVICE WAS NONFUNCTIONING. ACCORDING TO THE REPORTER, THE DEVICE OVERHEATED DURING THE CASE AND WOULD NO LONGER WORK. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085441 ↗
• MalfunctionJan 12, 2026Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MICRO TORNADO HP W HANDCONTROL SHAVER DEVICE HAD AN ELECTRICAL SHORT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032111 ↗
• MalfunctionJan 8, 2026Electrical Shorting; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING DEVICE MAINTENANCE, IT WAS DETERMINED THAT THE HAD AN ELECTRICAL SHORT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007549 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041824, K954465. One submission often covers many models, so check the product and lot details in each record.

• Z-0657-2016 · Nov 20, 2015 · Terminated
  FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0658-2016 · Nov 20, 2015 · Terminated
  FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0656-2016 · Nov 20, 2015 · Terminated
  FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0192-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the ar