3M Bair Hugger — Class II medical device recall Z-0599-2018

Terminated recall by 3M Company - Health Care Business, reported 2018-02-21, distributed nationwide. Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can ma

Recall number	`Z-0599-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	3M Company - Health Care Business, Saint Paul, MN, United States
Recall initiated	2018-01-23
Classified	2018-02-12
Reported by FDA	2018-02-21
Terminated	2020-08-21
Distributed	Nationwide (US)
Countries outside the US	AU, CA, CL, CR, EC, HK, ID, JP, KR, NZ, PH, PY, TH, UY
Reason classes	device malfunction
Lot numbers	`FR10361`
Model numbers	`63700`

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0599-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.