SmartLife 7126-120-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,065 adverse event reports that list this exact device (DI 07613327128819), received between Jul 24, 2018 and Oct 23, 2025 — classified as 1 injury, 1,064 malfunctions.

The most frequently reported specific device problem is “Fracture” (1,026 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,065 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 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 23369389 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DIFFICULT TO OPEN OR CLOSE - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369365 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  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 22647350 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THE HOUSING'S WELD FRACTURED DURING A PROCEDURE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22061992 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THE HOUSING'S WELD FRACTURED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO SURGICAL DELAY. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061980 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876863 ↗
• MalfunctionApr 2, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING IS FRACTURED AT THE WELD BEFORE A SURGERY. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755204 ↗
• MalfunctionJan 30, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING IS FRACTURED AT THE WELD. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274163 ↗
• MalfunctionJan 30, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING IS FRACTURED AT THE WELD. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274161 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201185 ↗
• MalfunctionJan 21, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200903 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING IS CRACKED FOUND DURING SURGERY. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197456 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078917 ↗
• MalfunctionNov 20, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 20737535 ↗
• MalfunctionNov 7, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING INSPECTION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632210 ↗
• MalfunctionOct 30, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569565 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499577 ↗
• MalfunctionOct 21, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. 1 EVENT HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494157 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO SURGICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407169 ↗
• MalfunctionSep 30, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20334220 ↗
• MalfunctionAug 14, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD FOUND DURING STERILIZATION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987738 ↗
• MalfunctionJul 29, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850391 ↗
• MalfunctionJul 24, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 2 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19823272 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO SURGICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716527 ↗
• MalfunctionJun 3, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THE CASE WAS COMPLETED, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19454378 ↗