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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Tattoo Pigments by Sierra Stain: Recall - Because of Possible Health Risk
AUDIENCE: Consumer, Health Professional, Dermatology
ISSUE: Sierra Stain is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. The recall was initiated after the recalling firm became aware of the results of the samples collected and analyzed by FDA, which tested positive for multiple microorganisms.
Commonly reported symptoms of tattoo ink associated infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Symptoms can be difficult to recognize, as other conditions (e.g. allergic reactions) may also present with similar findings.
Products were distributed to all 50 states through Amazon.
No illnesses have been reported to date.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The products being recalled are sold as water-based tattoo pigments.
RECOMMENDATIONS:
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Tattoo artists and retailers should avoid using or selling the recalled tattoo inks and dispose product in a sharps container or a similar biohazard container. SDS info is available upon request.
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Tattoo artists should be working in a professional environment such as a Tattoo Shop, as tattooing from home carries high risk of contamination in unsanitary conditions. Tattoo inks alone may not be the sole cause of adverse reactions, if not applied in a safe environment by professionals.
- Bloodline inks and Sierra Stain LLC are no longer in business and not manufacturing tattoo ink products. For questions contact sierrastain@gmail.com.
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Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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