OdneClean E-0003Recalls & reported problems
Odne AG · 1 OdneClean Device containing hose, metal rod holder, handpiece, multiple connection hoses, hose for disinfection, plug and cable, 500 sleeves, IFU / manual · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07649988156632), received between Jun 29, 2026 and Jun 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Discomfort1
- Inflammation1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Insufficient Device Problem Information
PATIENT RECEIVED INITIAL ROOT CANAL TREATMENT ON TOOTH #31. 3 DAYS FOLLOWING TREATMENT HE BEGAN TO DEVELOP SOME SWELLING. ON DAY 5 THE PATIENT HAD WORSENING TRISMUS. ENDODONTIST INSTRUCTED HIM TO GO TO THE EMERGENCY ROOM FOR A CT SCAN. A LATERAL PHARYNGEAL SPACE INFECTION WAS NOTED AND THE ORAL SURGEON ON STAFF EXTRACTED THE TOOTH. A SMALL AMOUNT OF PDL (PERIODONTAL LIGAMENT) WIDENING WAS NOTED AROUND THE APEX OF THE D (DISTAL) ROOT WITH A SLIGHT PERFORATION OF THE LINGUAL CORTICAL PLATE.
Patient problems: Discomfort; Inflammation; Pain; Swelling/ Edema
MAUDE report 25652841 ↗
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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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