Surgical Gown Recall: Chinese-Made Garments Recalled For Contamination Concerns, Canceling Some Surgeries

A sizeable recall has been issued for 2.9 million AAMI Level 3 surgical gowns made in China, due to concerns that the garments made not be properly sterilized. As a result, the medical community in the U.S. has been sent into turmoil, with many surgeries being canceled all across the country.

The recall comes from Ohio-based Cardinal Health, which said on Thursday that a Chinese supplier had not maintained proper “environmental conditions” and was not registered with the U.S. Food and Drug Administration (FDA). Some of the issues at the supplier included open windows, lack of hand sanitation, and food being consumed near production areas. The affected garments were made between September 2018 and January 2020.

Cardinal will issue instructions for handling the gowns by Feb. 3.

“I apologize to patients and our customers,” Cardinal CEO Mike Kaufmann said in a statement. “We understand the gravity of this situation and the disruptions to the healthcare system that will impact patient care. We are fully committed to making this right, and we are doing everything we can to ensure it never happens again.”

The problem with the gowns is also believed to have potentially affected other surgical supplies. Gowns are often shipped in packages with other tools, all of which must be sterile in order to be safe for use.

This supplier was also found to have been using an unregistered factory in 2018. At the time, Cardinal found no problems with the facility and did not report the incident to the FDA.

“We still don’t know if whether we’ve hit the worst of it or not,” Adam Levine, CEO of Tennessee’s Ballad Health said. Ballad will reportedly have to cancel and reschedule around 200 surgeries.