3M Company - Health Care Business: Medical Device Recall in 2018 - (Recall #: Z-0598-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Product Classification:

Class II

Date Initiated: January 23, 2018

Date Posted: February 21, 2018

Recall Number: Z-0598-2018

Event ID: 79002

Reason for Recall:

Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.

Status: Terminated

Product Quantity: 33108 cases of 5 units

Code Information:

Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated