Sierra Stain LLC is recalling three water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms that 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.
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.
The recall started after the company 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. 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 [email protected].
Affected Products:
| 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 |