3M Bair Hugger — Class II medical device recall Z-0598-2018
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-0598-2018 |
|---|---|
| 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 | R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366 |
| Model numbers | 63500 |
Product
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.
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-0598-2018. 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.