CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody recalled

3M Company - Health Care Business is recalling 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, distributed nationwide in the US. The recall was initiated on 23 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: FR10361

Quantity recalled36 cases of 5 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0599-2018
FDA event ID: 79002
Recalling firm: 3M Company - Health Care Business, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 23 Jan 2018
FDA classified: 12 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

23 Jan 2018	Recall initiated by company
12 Feb 2018	Classified by FDA	+20 days
21 Feb 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody recalled?

Yes. 3M Company - Health Care Business recalled 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody on 23 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-0599-2018.

Why was it recalled?

Which lots are affected?

Lot Numbers: FR10361

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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