Comply™ SteriGage™ 1243ARecalls & reported problems
3m Company · 3M™ Comply™ (SteriGage™) Chemical Integrator 1243A · 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 30707387469079), received between Aug 19, 2019 and Aug 19, 2019 — 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
- No Apparent Adverse Event1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2019No Apparent Adverse Event; No Apparent Adverse Event
A PEDIATRIC PATIENT UNDERWENT AN UNCOMPLICATED ABLATION FOR WOLFE PARKINSON WHITE SYNDROME. POST-OP IN PACU, THE PATIENT REPORTEDLY COUGHED UP A 3M¿ COMPLY¿STERIGAGE¿ STEAM CHEMICAL INTEGRATOR. IT WAS ALLEGED THAT THE INDICATOR HAD WORKED ITS WAY INTO THE LARYNGOSCOPE BLADE AND WAS SILVER SIDE UP. THE PATIENT WAS REPORTEDLY UNHARMED.
Patient problems: Not Applicable
MAUDE report 8906604 ↗
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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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