SPORVIEW SELF-CONTAINED STEAM BI SCS-106Recalls & reported problems
SPS Medical Supply Corp. · For use in biologically monitoring all steam sterilizers · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10732224721238), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED INHALATION/IRRITATION AND BECAME UNCONSCIOUS AFTER BREAKING A SPORVIEW SELF-CONTAINED BIOLOGICAL INDICATOR. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Discomfort
MAUDE report 15259220 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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