CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Biotrol Purit Clean-It General Purpose Ultrasonic Cleaner recalled
Young Dental Manufacturing I is recalling Biotrol Purit Clean-It General Purpose Ultrasonic Cleaner, distributed in 10 states. The recall was initiated on 23 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0008-2025
- FDA event ID
- 95302
- Recalling firm
- Young Dental Manufacturing I, Earth City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2024
- FDA classified
- 1 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 23 Aug 2024 | Recall initiated by company | |
| 1 Oct 2024 | Classified by FDA | +39 days |
| 9 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Where it was distributed
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
ArizonaIdahoMarylandNevadaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Which lots are affected?
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Where was it sold?
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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