3M Recalls Bair Hugger Temperature Sensors Due to Programming Error
3M is recalling Bair Hugger temperature sensors because a programming error may cause the device to display a temperature lower than the patient's actual body temperature.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to inaccurate patient monitoring (risk-of-harm product) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
3M Company - Health Care Business is recalling 153 cases (3,825 sensors) of the 3M Bair Hugger Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000). The recall involves specific lot numbers with expiration dates in August 2020.
The recall was initiated after an investigation confirmed that a programming translation error could occur in a small amount of the sensors. This error could lead to a temperature readout that is lower than the patient's actual temperature. The affected products were distributed in California, Michigan, Illinois, Missouri, Minnesota, Georgia, Canada, and Switzerland.
Healthcare providers and consumers should stop using the affected sensors and contact 3M for further instructions or a replacement.
The recalled product
- Product
- 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
- Manufacturer
- 3M Company - Health Care Business
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers: 17230
- Exp. 2020 Aug 18
- 17233
- Exp. 2020 Aug 21
- 17234
- Exp. 2020 Aug 22
- 17241
- Exp. 2020 Aug 29
Distribution
Related recalls
Same manufacturer · 3M Company - Health Care Business
See all →- High3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
FDA (Devices) · 2025-01-01
- High3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination
FDA (Devices) · 2024-10-16
- Moderate3M Durapore Surgical Tape incorrectly labeled with extended shelf life
FDA (Devices) · 2024-05-01
- Moderate3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects
FDA (Devices) · 2024-04-10
- High3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
FDA (Devices) · 2024-02-28
Same hazard · inaccurate reading
See all →- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction
FDA (Devices) · 2021-05-26