Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Cosmetics
- Reason for Announcement:
-
Recall Reason Description
Tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa.
- Company Name:
- U.S. Food and Drug Administration
- Brand Name:
-
Brand Name(s)
- Product Description:
-
Product Description
Sacred Tattoo Ink, Raven Black; CI# 77266; Lot#: RB0624; Best Before: June 28 2027
Sacred Tattoo Ink, Sunny Daze; CI# 21095; Lot#: SD1124; Best Before: Nov 1 2027
FDA Announcement
Audience
- Consumers who are considering a new tattoo
- Tattoo artists
- Retailers of tattoo inks
Product
FDA laboratory analysis has found that the following tattoo inks are contaminated with pathogenic microorganisms:
- Sacred Tattoo Ink, Raven Black; CI# 77266; Lot#: RB0624; Best Before: June 28 2027
- Sacred Tattoo Ink, Sunny Daze; CI# 21095; Lot#: SD1124; Best Before: Nov 1 2027
Purpose
The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa. Tattoo inks contaminated with pathogenic microorganisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure, since there is an increased risk of infection any time the skin barrier is broken.
Commonly reported symptoms of tattoo-ink-associated infections include the appearance of rashes or lesions consisting of red papules in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Indications of an infection can be difficult to recognize as other conditions (e.g., allergic reactions) may initially have similar signs and symptoms, leading to misdiagnosis and ineffective treatments.
Summary of Problem and Scope
The FDA has become aware of contaminated tattoo inks through its routine surveys of marketed tattoo inks, and subsequent microbiological analysis of sampled tattoo inks. The FDA has identified 2 tattoo inks contaminated with bacteria harmful to human health through samples collected as part of routine surveillance activities. Tattoo inks were analyzed using methods described in the Bacteriological Analytical Manual Chapter 23: Microbiological Methods for Cosmetics, which are the general methods used to determine bacterial contamination of cosmetics.
Recommendations for Consumers
Ask the tattoo artist or studio about the tattoo inks they use and avoid the tattoo inks listed above, due to risk of infection and injury.
Recommendations for Tattoo Artists, and Retailers
Avoid using or selling the tattoo inks mentioned above, due to risk of infection and injury.
FDA Monitoring
The FDA will continue to work with manufacturers and retailers to help ensure contaminated products are removed from the market.
Who to Contact
Health care professionals and consumers are encouraged to report any adverse health experiences at FDA's SmartHub.
Sacred Tattoo Ink Raven Black (Manufactured by Sacred Tattoo Ink)
Sacred Tattoo Ink Sunny Daze (Manufactured by Sacret Tattoo Ink)
