Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Cosmetics
Reason for Announcement:

Recall Reason Description

Contaminated with high concentrations of microorganisms

Company Name:
Sierra Stain LLC
Brand Name:
Product Description:

Product Description

Water Based Tattoo Pigments


Company Announcement

Sierra Stain LLC of Carson City, Nevada is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. 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.

Product Label

Manufacturing Codes

Microorganisms Identified

Bloodline 1/2oz/15mL
CAROLINA BLUE
Water Based Tattoo Pigments
Batch #1 Lot BL23
Manufactured 07/01/23
Expires 07/01/26
Citrobacter braakii
Citrobacter farmer
Pseudomonas fluorescens
Achromobacter xylosoxidans
Ochrobactrum anthropic
Cupriavidus pauculus
Bloodline 1oz/30mL
ALL PURPOSE BLACK
Water Based Tattoo Pigments
Batch #1 Lot BL23
Manufactured 07/01/23
Expires 07/01/26
Acetobacter senegalensis
Bloodline 1/2oz/15mL
UV CHINA PINK
Water Based Tattoo Pigments
Batch #1 Lot SC23
Manufactured 06/23
Expires 06/26
Curtobacterium citreum/pusillum

Products are packaged in plastic rounded bullet shape PET bottles with black dispense screw top and were distributed to all 50 states through Amazon.

No illnesses have been reported to date.

Reason for recall: 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.

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.

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.

Consumers should also consider reporting their injury to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program. The FDA encourages consumers with questions about product safety to submit an inquiry, or to visit www.fda.gov/fcic for additional information.

Bloodline inks and Sierra Stain LLC are no longer in business and not manufacturing tattoo ink products. For questions contact sierrastain@gmail.com.