Stryker SRBI30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07798164678793), received between Dec 26, 2023 and Jan 10, 2024 — classified as 12 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, THE AUTO-READER INCUBATOR KEPT SHOWING POSITIVE RESULTS FOR THE BIOLOGICAL INDICATORS AFTER THE STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482956 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SALES REPRESENTATIVE REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478140 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DISTRIBUTOR REPORTED THE BIOLOGICAL INDICATOR IS SHOWING POSITIVE RESULTS AFTER THE STERILIZATION PROCESES, NOT ALLOWING THE LOADS TO BE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477203 ↗
• MalfunctionJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WERE RECURRING BIS FAILING FOLLOWING COMPLETED VP4 CYCLES. THE VP4 DID NOT REGISTER ANY ERROR CODES OR CANCEL ANY LOADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467518 ↗
• MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SALES REPRESENTATIVE REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446634 ↗
• MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445432 ↗
• MalfunctionJan 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED AUTOREADER MALFUNCTION BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444255 ↗
• MalfunctionJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437800 ↗
• MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER AT MAYO BALDWIN CLINIC EXPERIENCE A POSITIVE BI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401529 ↗
• MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER AT (B)(6) CLINIC EXPERIENCE A POSITIVE BI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401393 ↗
• MalfunctionDec 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER INFORMED THAT A NEW DEVICE SHOWED AN INTENSE SMOKE SMELL. NO FURTHER INFORMATION WAS PROVIDED AS IF IT WAS OUT OF THE BOX OR AS A RESULT OF THE FIRS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392758 ↗
• MalfunctionDec 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HOSPITAL REPORTED THAT THERE WERE THREE POSITIVE BIS AFTER A COMPLETE STERILIZATION PROCESS. CLINICAL REQUESTED THE CUSTOMER TO RUN AN EMPTY CYCLE WITH JUST THE BI (FOR VALIDATION PURPOSES) AND THE BI RESULTED POSITIVE. THERE'S A POSSIBILITY OF BI MALFUNCTION, WHICH MAY CAUSE THE DELAY IN PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392584 ↗