Biotrol PC016Recalls & reported problems
Young Dental Manufacturing I, LLC · PURIT CLEAN-IT 16 oz. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 23, 2024Open, Classified
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Z-0008-2025 · Root cause: Material/Component Contamination · FDA record ↗
Other Cleaner, Ultrasonic, Medical Instrument devices
- Triton 72Ultra Clean Systems, Inc. · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Triton 36Ultra Clean Systems, Inc. · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
- Prolystica 1C3308Steris Corporation · Cleaner, ultrasonic, medical instrument8 reports
- Prolystica 1C2408Steris Corporation · Cleaner, ultrasonic, medical instrument3 reports
- InnoWave UnityMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument2 reports
- Prolystica 1C2308Steris Corporation · Cleaner, ultrasonic, medical instrument2 reports
- InnoWave IWULTRAMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument1 report
- InnoWave IWULTRAPLMedisafe Uk Limited · Cleaner, ultrasonic, medical instrument1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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