OralKleen V1Recalls & reported problems
Oralkleen, LLC · Electric Suctioning Toothbrush · Class 1
Data updated Oct 13, 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 00850030081001), received between Mar 1, 2023 and Mar 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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.
Most reported problems
Device problems
- Defective Component1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2023Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component
AN EXPERIENCED ICU NURSE HAD JUST STARTED TO BRUSH A COOPERATIVE PATIENT'S TEETH USING ONE OF THE PREPACKAGED REPLACEMENT TOOTHBRUSH HEADS. SHE SAID THE PATIENT BARELY BIT DOWN AND THE BRUSH HEAD POPPED OFF. IT LANDED ON HIS TONGUE AND SHE QUICKLY STUCK HER FINGERS INSIDE HIS MOUTH TO FISH IT OUT AND SAVE IT. THE FAILED PARTS WERE GATHERED AND RETURNED TO A COMPANY REPRESENTATIVE FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16462812 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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