Medihoney Gel Lawsuit Alleges Recalled Wound Dressing Caused Infection, Kidney Failure

At least three Medihoney Wound & Burn Dressing recalls have been announced in recent months, due to the risk of dangerous infections.

A North Carolina woman has filed a product liability lawsuit alleging that the use of recalled Medihoney Wound Gel to treat an ulcer on her left foot resulted in a severe infection, which caused her to to be hospitalized and ultimately develop kidney failure.

The complaint (PDF) was brought by Julia Hollen in North Carolina Superior Court on September 4, naming Integra Lifesciences Corporation, the manufacturer of Medihoney Wound & Burn Dressing, as the sole defendant.

According to the company’s marketing, the gel is a medical-grade wound dressing made with Active Leptospermum Honey, which is promoted as drawing fluid from wounds while maintaining a moist environment to encourage healing. It is widely recommended for chronic, hard-to-heal wounds and burns.

However, safety concerns were raised in October 2024, when the U.S. Food and Drug Administration (FDA) announced a Class 2 recall of 120,124 units of Medihoney Gel. The affected products, which carried expiration dates between August 1, 2024, and June 1, 2028, had been distributed nationwide from December 17, 2020, through July 22, 2024.

The FDA indicated the recall was due to the risk of tiny holes forming in the applicator pin pouch, which could compromise sterility. Because the gel is applied directly to open wounds, any breach in sterility may lead to dangerous infections that can result in hospitalization, surgical intervention or even death.

According to her lawsuit, Hollen purchased Medihoney Wound & Burn Gel from Amazon.com at the direction of her health care provider in the fall of 2022, to treat a left foot ulcer, which is an open sore that can develop when a wound does not heal properly.

The complaint indicates that Hollen used the wound gel with its appropriate product applicator as the packaging directed for nearly three months.

However, Hollen says she sought treatment for symptoms of nausea, fever and emesis in December 2022, which her provider attributed to a urinary tract infection. Then, on January 3, 2023, her left foot split into an open wound, at which point Hollen went to the hospital, where she was immediately taken in for surgery due to a severe left foot infection.

Hollen indicates that she underwent two additional surgeries, developed kidney failure that required dialysis and blood transfusions, and ultimately remained hospitalized for 22 days.

The lawsuit points out that Hollen was not aware of the Medihoney Gel recall until she received a notice from Amazon on January 31, 2025, informing her of the FDA’s October 2024 recall announcement.

“As a direct and proximate result of Plaintiff’s use of the MediHoney Wound & Burn Dressing, Plaintiff suffered an infection of her left foot which resulted in multiple surgeries, hospitalization, significant pain, permanent disfigurement and permanent impairment of her left foot.”

— Julia Hollen v. Integra Lifesciences Corporation

Hollen raises allegations of negligence and breach of implied warranty of merchantability against Integra. She is seeking actual damages.

Medihoney Wound Gel Infection Concerns

The Medihoney recall that Hollen claims led to her infection is not the only sterility issue the product has faced in recent years.

In February 2025, a Medihoney Wound Gel recall was announced by the FDA due to the possibility of product induction seals not being completely closed on tube packaging, leading to concerns about product sterility. This recall affects approximately 12,166 units.

The FDA also announced a separate Medihoney recall on September 3 of this year, which addressed additional packaging failures that could lead to breaches in the products’ sterile barriers. At least 15,441 units are covered under this recall.

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