Home › Empowered Products, Inc. › Pink
Pink
Empowered Products, Inc. · Model Water - 8oz · UDI-DI 00891306000968
1
510(k) clearances
171
Adverse events (1 deaths)
7
Recalls
124
Facilities
Description
8oz bottle of water based lubricant intended for use during intercourse or masturbation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2012-07-02 | Mc-NEIL-PPC, Inc. | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device |
| 2009-07-10 | Memphis Fertility Laboratory Inc | Product was marketed without a 510(k). |
| 2008-09-22 | INGfertility, LLC | Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci). |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.