Infection Outbreak Leads to Home Tattoo Ink Kit Recall

Federal regulators are warning consumers that some home tattoo needles and ink kits sold on the internet may be unsafe, due to microbial contamination that may pose an infection risk. 

An FDA consumer warning was issued on August 7, in the wake of a White & Blue Lion Inc. tattoo inks, needles and kits recall last month for all tattoo ink colors, needles individually packaged and packaged in groups of five, tattoo tubes and ink cups.

The recall was issued after FDA lab testing confirmed microbial bacterial contamination in both the inks and needles. One confirmed report of skin infection was identified after the consumer used the products in question. Other infections involving contaminated products with similar packaging have also been reported, but not officially linked to the recall.

A variety of pathogenic organisms were isolated and identified in the products, ranging from gram negative bacteria, bacillus spp. Sphingomonas paucimobilis to clostridium botulinum.

The products are sold separately and in kits. They are sold by White & Blue and 8Decades online through Amazon and eBay. The kits are sold as in-home tattoo kits.

The contaminated products were recalled July 11, 2014, but officials say other distributers may still be selling the products, placing consumers at unnecessary risk.

Some of the recalled ink bottles have a multicolored Chinese dragon with black and white lettering. Others are missing manufacturer information.

“Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems,” said Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors.

Injecting contaminated ink into the skin or using contaminated needles may cause infections at the site of the tattoo. This may lead to redness, swelling, weeping wounds, blemishes, or excessive paint at the tattoo site.

Hepatitis, staph infections and the super bug MRSA have been tied to infections from tattoos. Typically this is a result of dirty needles or tools, in this case contaminated products.

Some people may experience an infection even after the tattoo site has healed, causing permanent scarring. The FDA has received reports of infection and adverse reactions years after a tattoo was done.

Health officials say the contaminants in White & Blue Lion inks and needles may lead to bacterial infection, which can also lead to sepsis. Sepsis is a potentially life-threatening complication of infection which spreads to the bloodstream.

Signs of sepsis may include fever, shaking, chills and sweats. Treatment may include antibiotics, hospitalization and surgery.

“Reporting an infection to FDA and the artist is important in order for FDA to investigate, and to enable the artist to take steps to prevent others from becoming infected,” said epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.