Washington, DC (May 22, 2024) – The FDA has issued a safety alert advising consumers, tattoo artists, and retailers to avoid using or selling certain tattoo inks that have been found to be contaminated with microorganisms. This alert, initially released on May 17 and updated on May 21, highlights the serious risks posed by these contaminated products.
Audience:
- Consumers Considering a New Tattoo
- Tattoo Artists
- Retailers of Tattoo Inks
Recalled Products:
The following tattoo inks have been voluntarily recalled due to contamination:
- Scalpaink SC, Scalpaink PA, and Scalpaink AL basic black tattoo inks by Scalp Aesthetics (all lots distributed from 8/6/2018 through 10/1/2018) – Recall Completion Date 5/17/2019
- Dynamic Color – Black tattoo ink by Dynamic Color Inc (lots 12024090 and 12026090)
- Solid Ink-Diablo (red) tattoo ink by Color Art Inc. (dba Solid Ink) (lot 10.19.18)
Purpose:
The FDA aims to alert consumers, tattoo artists, and retailers of the potential for serious injury from using these contaminated tattoo inks. The presence of harmful bacteria in the inks can cause infections and significant health issues when injected into the skin during tattooing. Infection risks increase whenever the skin barrier is breached.
Reported Symptoms:
Common symptoms of infections caused by contaminated tattoo inks include:
- Appearance of rashes or lesions with red papules in the tattooed areas
- Potential for permanent scarring
- Difficulty in recognizing infections as symptoms may resemble other conditions like allergic reactions, leading to possible misdiagnosis and ineffective treatments
Problem Summary:
The FDA discovered the contamination during its FY2018-2019 inspections of distributors and manufacturers, routine surveys, and microbiological analysis of tattoo inks. Six contaminated inks have been identified, and the FDA is working with manufacturers and distributors to remove these products from the market. The analysis methods are detailed in the Bacteriological Analytical Manual Chapter 23: Microbiological Methods for Cosmetics.
Recommendations:
For Consumers:
- Inquire about the tattoo inks used by your tattoo artist or studio.
- Avoid the recalled inks listed above due to the risk of infection and injury.
For Tattoo Artists and Retailers:
- Do not use or sell the recalled tattoo inks mentioned above.
FDA Actions:
The FDA will continue collaborating with manufacturers and retailers to ensure the removal of contaminated products from the market.
Reporting Problems:
Consumers experiencing symptoms of infection or injury after receiving a tattoo should consult a healthcare professional and notify their tattoo artist. They are also encouraged to report their injuries to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program. For further inquiries or additional information on product safety, visit www.fda.gov/fcic.
