3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3...
FDA Device Recall #Z-0598-2018 — Class II — January 23, 2018
Recall Summary
| Recall Number | Z-0598-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 23, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | 3M Company - Health Care Business |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 33108 cases of 5 units |
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.
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.
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.
Lot / Code Information
Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366
Other Recalls from 3M Company - Health Care Business
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0743-2025 | Class II | Clarity Precision Grip Attachments, for use in ... | Nov 22, 2024 |
| Z-0038-2025 | Class II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. S... | Aug 14, 2024 |
| Z-1633-2024 | Class II | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Mar 20, 2024 |
| Z-1475-2024 | Class II | 3M Tube Securement Device, Small, 1.7 IN/PO x 2... | Feb 20, 2024 |
| Z-1170-2024 | Class II | 3M Specialty Blade Assembly, REF 9660,70-2011-8... | Jan 12, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.