CoFirm 10 Steam Biological Indicators CI10BI25Recalls & reported problems
SPS Medical Supply Corp. · Self-Contained Biological Indicator, 10 hour incubation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10732224000463), received between May 8, 2018 and Dec 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- Chemical Exposure1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Break; Break
OFFICE MANAGER REPORTED A BI VIAL EXPLODED AS AN ASSISTANT REMOVED IT FROM THE INCUBATOR. THE VIAL WAS COLD. PIECES OF GLASS SCRATCHED HER FACE.
Patient problems: Laceration(s)
MAUDE report 23707665 ↗InjuryMay 8, 2018Material Fragmentation; Material Fragmentation
THE FACILITY REPORTED A DENTAL ASSISTANT WAS INJURED WHILE USING CROSSTEX CONFIRM 10 BIOLOGICAL INDICATORS. IT WAS REPORTED THE AMPOULE BURST, RESULTING IN LIQUID SPLASHING ONTO AND SCRATCHING THE DENTAL ASSISTANT'S FACE. AFTER THE AMPOULE BURST, THE DENTAL ASSISTANT FLUSHED HER EYES AND SOUGHT MEDICAL ATTENTION TO ENSURE NO ADDITIONAL GLASS PARTICLES REMAINED IN HER EYE. THE AFFECTED PERSONNEL WAS RELEASED WITHOUT ANY ISSUES BEING FOUND.
Patient problems: Chemical Exposure
MAUDE report 7496816 ↗
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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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