Sonopet iQRecalls & reported problems across all models
Stryker Corporation · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 201
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 16 models of Sonopet iQ by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 201 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2019 and Jul 22, 2026 — classified as 25 injuries, 176 malfunctions.
The most frequently reported specific device problem is “Fracture” (83 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
Reports received per month, all models
Most reported Sonopet iQ problems
Device problems
- Fracture83
- Overheating of Device57
- Inability to Irrigate41
- Adverse Event Without Identified Device or Use Problem15
- Excessive Heating7
- Accessory Incompatible1
- Activation Failure1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions158
- Burn(s)18
- No Consequences Or Impact To Patient11
- Insufficient Information10
- Partial thickness (Second Degree) Burn4
- Rupture4
- Superficial (First Degree) Burn4
- Muscle Weakness/Atrophy3
Sonopet iQ models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sonopet iQ 5500255000Instrument, ultrasonic surgical47 reports
- Sonopet iQ 550025B114Instrument, ultrasonic surgical43 reports
- Sonopet iQ 550025B302Instrument, ultrasonic surgical23 reports
- Sonopet iQ 5500050000Instrument, ultrasonic surgical22 reports
- Sonopet iQ 550025S307Instrument, ultrasonic surgical18 reports
- Sonopet iQ 550025B315Instrument, ultrasonic surgical10 reports
- Sonopet iQ 550025B318Instrument, ultrasonic surgical9 reports
- Sonopet iQ 550025B107Instrument, ultrasonic surgical8 reports
- Sonopet iQ 5500573000Instrument, ultrasonic surgical4 reports
- Sonopet iQ 550025B312Instrument, ultrasonic surgical4 reports
- Sonopet iQ 550025B303Instrument, ultrasonic surgical4 reports
- Sonopet iQ 550025S310Instrument, ultrasonic surgical3 reports
- Sonopet iQ 550025S309Instrument, ultrasonic surgical3 reports
- Sonopet iQ 550025B319Instrument, ultrasonic surgical1 report
- Sonopet iQ 550025S316Instrument, ultrasonic surgical1 report
- Sonopet iQ 550025B317Instrument, ultrasonic surgical1 report
Recent Sonopet iQ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907827 ↗MalfunctionJul 22, 2026Inability to Irrigate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907784 ↗MalfunctionApr 22, 2026Inability to Irrigate
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INABILITY TO IRRIGATE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954419 ↗MalfunctionApr 22, 2026Overheating of Device
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954316 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954022 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953978 ↗MalfunctionApr 22, 2026Inability to Irrigate
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953806 ↗MalfunctionApr 22, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953793 ↗MalfunctionJan 29, 2026Inability to Irrigate
THE MANUFACTURER SALES REP REPORTED THAT THE DEVICE DID NOT IRRIGATE. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.
Patient problems: Insufficient Information
MAUDE report 24208367 ↗MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163985 ↗MalfunctionJan 23, 2026Inability to Irrigate
MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163590 ↗MalfunctionJan 23, 2026Overheating of Device
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163576 ↗MalfunctionJan 23, 2026Fracture
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163402 ↗MalfunctionJan 23, 2026Inability to Irrigate
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: INABILITY TO IRRIGATE. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163400 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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