DYONICS 25Recalls & reported problems across all models

We found 2 models of DYONICS 25 by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Sep 30, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DYONICS 25 problems

DYONICS 25 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DYONICS 25 7211010F

  ARTHROSCOPE
  26 reports
• DYONICS 25 72200211

  ARTHROSCOPE
  1 report

Recent DYONICS 25 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING SET UP, THE DYONICS 25 CONTROL UNIT DID NOT ADJUST. IT WAS PUMPING AT A HIGH RATE AND DID NOT ADJUST ACCORDING TO PRESSURE SETTINGS. PRESSURE WAS HIGHER THAN INTENDED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23187541 ↗
• MalfunctionAug 4, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING SET UP, THE DYONICS 25 CONTROL UNIT WAS OVER PRESSURIZING. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700247 ↗
• InjuryJul 5, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE DYONICS 25 CONTROL UNIT PUMP WAS CAUSING AN EXTREME EXTRAVASATION OF THE SHOULDER, THE PATIENT WAS HELD FOR AN EXTRA HOUR IN RECOVERY UNTIL THE FLUID DRAINED OUT ENOUGH AND THE SURGEON FELT COMFORTABLE OF IT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 19683190 ↗
• MalfunctionApr 3, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, THE DYONICS 25 CONTROL UNIT WAS NOT PRESSURIZING CORRECTLY AND OVER PUMPS FLUID. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667737 ↗
• MalfunctionMay 21, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE CALIBRATION ON THE DYONICS CONTROL UNIT WAS NOT HOLDING AT THE PROPER SET PRESSURE LEVEL. THE PUMP WAS RUNNING TOO HIGH AND COULD NOT BE CORRECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466562 ↗
• MalfunctionNov 30, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, THE DYONICS CONTROL UNIT WAS NOT HOLDING PRESSURE PROPERLY. PRESSURE WAS INCREASING SPORADICALLY. INCIDENT OCCURRED WHILE SETTING-UP FOR A KNEE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892865 ↗
• MalfunctionSep 10, 2021Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DYONICS CONTROL UNIT INFUSED MORE LIQUID THAN USUAL TO THE SHOULDER'S PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456355 ↗
• MalfunctionMay 7, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DYONICS CONTROL UNIT HAD A LACK OF PRESSURE ISSUE DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE OR A DELAY IN THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795066 ↗
• MalfunctionMay 7, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE DYONICS CONTROL UNIT HAD A LACK OF PRESSURE ISSUE DURING AN UNKNOWN PROCEDURE. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE OR A DELAY IN THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794993 ↗
• InjuryMar 17, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE "DYONICS 25 CONTROL SYSTEM" SWITCHED OFF AND TURNED BACK ON RESULTING IN SURGE OF FLUID INTO THE PATIENT'S JOINT CAUSING INTRAVASATION. ALTHOUGH THE SURGERY WAS NOT SIGNIFICANTLY DELAYED, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Extravasation

  MAUDE report 11507138 ↗
• MalfunctionMar 14, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR AN UNKNOWN PROCEDURE, THE CONTROL UNIT WAS OVERPRESSURING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479042 ↗
• MalfunctionFeb 10, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DYONICS 25 CONTROL UNIT WAS NOT REGULATING THE JOINT PRESSURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310932 ↗
• MalfunctionJan 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A SURGERY THE CONTROL UNIT PUMP WAS LOOSING THE SEAL CAUSING THAT THE CASSETTES TO COME AFAR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135263 ↗
• MalfunctionDec 8, 2020Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CONTROL UNIT WAS NOT HOLDING PRESSURE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973042 ↗
• MalfunctionOct 9, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE CONTROL UNIT KEEPS ALARMING. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; NO COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10656925 ↗

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