3M Bair Hugger Warming Blanket Recall: Risk of Limited Inflation During Use
3M recalls specific models of Bair Hugger warming blankets due to potential airflow issues causing limited inflation. Affected units include lot numbers R10359-R10366. Contact 3M for details.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
3M is recalling certain Bair Hugger warming blankets that may not inflate properly during use, risking patient hypothermia. This recall affects specific lot numbers and requires immediate attention to prevent safety issues. Read more at govinfonow.com/recall/72110-3m-bair-hugger-warming-blanket-recall-risk-of-limited-inflation.
Source Summary by GovInfoNow · govinfonow.com/recall/72110-3m-bair-hugger-warming-blanket-recall-risk-of-limited-inflation · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0598-2018
Cite this page
“3M Bair Hugger Warming Blanket Recall: Risk of Limited Inflation During Use.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72110-3m-bair-hugger-warming-blanket-recall-risk-of-limited-inflation. Based on FDA recall #Z-0598-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2018%22&limit=1).
Why it’s dangerous
A design change in these blankets can cause airflow to become restricted, leading to partial or limited inflation. This may prevent the blanket from effectively warming patients, increasing the risk of hypothermia.
Who’s affected
Healthcare providers using the 3M Bair Hugger Full Access Underbody Warming Blanket (models 63500 and 63700) with lot numbers R10359 through R10366 are most at risk. Patients receiving care with these blankets could experience hypothermia if the blanket fails to inflate properly.
How to tell if you have this one
Check the product label for lot numbers R10359 to R10366. The 3M Bair Hugger Full Access Underbody Warming Blanket (models 63500 and 63700) is the affected item.
- Brand
3M- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0598-2018 | 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.; Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366 | 33108 cases of 5 units |
| Z-0599-2018 | 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.; Lot Numbers: FR10361 | 36 cases of 5 units |
What to do — step by step
Check Product Label
Look for lot numbers R10359 through R10366 on the blanket.
Contact 3M for Details
Reach out to 3M directly for specific instructions on how to handle the affected units.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0598-2018 (January 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0598-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.