CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report
3M Bair Hugger(TM) Normothermia System recalled
3M Company - Health Care Business is recalling 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors, distributed in California, Georgia, Illinois, Michigan, Minnesota, Missouri. The recall was initiated on 17 Oct 2017 and the FDA has classified it as Class II.
Check your package
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-0114-2018
- FDA event ID
- 78327
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2017
- FDA classified
- 18 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Patient Monitors
Timeline
| 17 Oct 2017 | Recall initiated by company | |
| 18 Nov 2017 | Classified by FDA | +32 days |
| 29 Nov 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Where it was distributed
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
Questions about this recall
Is 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors recalled?
Yes. 3M Company - Health Care Business recalled 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors on 17 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0114-2018.
Why was it recalled?
During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.
Which lots are affected?
Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
Where was it sold?
CA, MI, IL, MO, MN, GA, and Canada, Switzerland
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.
More recalls from 3M Company - Health Care Business
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clarity Precision Grip Attachments, for use in orthodontic treatment recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide |
| Device | CLASS II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V recalled | 3M Company - Health Care Business | Other | Nationwide |
| Device | CLASS II | 3M Durapore Surgical Tape recalled by 3M Company - Health Care | 3M Company - Health Care Business | Labeling Errors | Nationwide |
| Device | CLASS II | 3M Tube Securement Device, Small/PO/PO recalled | 3M Company - Health Care Business | Sterility | Nationwide |
| Device | CLASS II | 3M Specialty Blade Assembly recalled by 3M Company - Health Care | 3M Company - Health Care Business | Temperature Abuse | MN |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |