Food, drugs, devices › Young Dental Manufacturing I, LLC
Device recall: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut
Young Dental Manufacturing I, LLC (Earth City, MO) initiated this device recall on 23 Aug 2024; FDA lists 1 product record under event 95302, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Young Dental Manufacturing I, LLC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Young Dental Manufacturing I, LLC, Earth City, MO.
Reason for recall
"The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination."
Distribution
"Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0008-2025 | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution. | 1,391 units | Class II | Ongoing | 9 Oct 2024 |
Context
Other enforcement events for Young Dental Manufacturing I, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 May 2024 | Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse | Device | Class II | 1 |
| 6 Oct 2023 | CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles | Device | Class II | 1 |
| 23 May 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | Device | Class II | 1 |
| 5 Dec 2022 | Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 | Device | Class III | 1 |
All 5 events for Young Dental Manufacturing I, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.