Sterim SRI-050Recalls & reported problems
True Indicating LLC · Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00197644080601), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT WHEN AN EMPLOYEE REMOVED THE SELF-CONTAINED BIOLOGICAL INDICATOR FROM THE INCUBATOR, A PIECE OF THE ACTIVATED (CRUSHED) BIOLOGICAL INDICATOR VIAL CONTACTED THEIR FACE RESULTING IN A SCRATCH. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Pain
MAUDE report 23842724 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.