RB Health (US) LLC
FDA Regulatory Profile
RB Health (US) LLC appears in FDA public data with 1 recall, 15 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1179-2023, Class III) was initiated on August 29, 2023. Its most recent 510(k) clearance was granted on February 28, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1179-2023 | Class III | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, fu | August 29, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241617 | Durex Polyisoprene Condom | February 28, 2025 |
| K230781 | Belle Sensilube | June 20, 2023 |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | March 7, 2023 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | November 7, 2022 |
| K222068 | Durex Penck III Regular | October 12, 2022 |
| K211152 | Durex Condom with Benzocaine | May 11, 2022 |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | March 1, 2022 |
| K213647 | Durex Patronus Wide | February 17, 2022 |
| K211088 | Grosz Play Feel | July 9, 2021 |
| K200672 | Durex Penck Standard, Durex Penck XL | November 6, 2020 |
| K201186 | KY Grosz Jelly | July 30, 2020 |
| K193032 | KY Grosz Liquid | April 20, 2020 |
| K192982 | KY Grosz UltraGel | April 14, 2020 |
| K183505 | KY Banksy Moisture | May 17, 2019 |
| K183302 | KY Banksy Aloe | April 16, 2019 |