3M Bair Hugger Recall Issued For Certain Surgical Warming Blankets

3M Company has announced a recall for 165,000 Bair Hugger forced air warming blankets, which are found in operating rooms nationwide, due to airflow problems that may result in incomplete warming therapy for patients undergoing surgical procedures. 

The 3M Bair Hugger recall was announced in a field safety notice issued on January 25, and the FDA declared the action a class 2 recall on Monday.

The Bair Hugger is a forced air warming blanket used to regulate patients’ body temperatures during surgery, particularly hip and knee joint replacement surgeries. According to the recall notice, the devices are susceptible to unintended airflow occlusion, which can lead to them not inflating correctly or in a limited fashion.

The recall comes amid a growing number of Bair Hugger lawsuits being pursued against 3M over infection risks, which are allegedly caused by design problems with the warming blanket that cause bacteria and contaminants from the operating room floor to enter the sterile surgical site.

Five lots of Bair Hugger surgical warming blankets are impacted by this latest recall, which appears unrelated to the infection cases, but does involve concerns about the airflow design.

“During a recent investigation, 3M confirmed that the affected blankets are more susceptible to unintended occlusion of airflow resulting in partial or limited inflation during use,” the safety notice warns. “If blankets are only partially inflated during use in surgery, the potential exists for incomplete warming therapy to be given to a patient.”

Recalled warming blankets include 3M Bair Hugger Normothermia System, Full Access Underbody Warming Blanket, Model 63500 with lot numbers R10359, R10361, R10362, R10363, and R10364, which were distributed after October 26, 2017. The recall affects a total of 33,108 cases of five units each and were distributed worldwide.

3M is calling on its customers to immediately identify if they have a recalled Bair Hugger blanket, return a confirmation form that was attached to the field safety notice, and to dispose of all recalled blankets. The company indicates it will provide customers with replacement products. Customers with questions should contact their 3M representative.

Bair Hugger Litigation

There are currently about 4,200 hip infection lawsuits and knee infection lawsuits pending against 3M Company in the federal court system, each involving similar claims that the Bair Hugger is defective and unreasonably dangerous for use during joint replacement surgery.

Plaintiffs maintain that they have been left with severe and debilitating deep joint infections after use of a Bair Hugger blanket, typically resulting in the need for multiple surgical procedures and lengthy infection treatment.

Given similar questions of fact and law raised in complaints filed nationwide, the federal litigation has been centralized before U.S. District Judge Joan Ericksen in the District of Minnesota for coordinated discovery and pretrial proceedings, as part of an MDL, or multidistrict litigation.

As part of the coordinated pretrial proceedings in the MDL, Judge Ericksen has established a “bellwether” program, where an initial group of cases have been prepared for early trial dates, which are designed to test how juries may respond to certain evidence and testimony that is likely to be repeated throughout the cases.

Although the outcome of the Bair Hugger bellwether trials will not be binding on other cases in the litigation, they will be closely watched by lawyers involved in the cases and may help facilitate eventual hip and knee infection settlements to avoid the need for hundreds of individual trials in courts nationwide.