3M Bair Hugger — Class II medical device recall Z-0114-2018
Terminated recall by 3M Company - Health Care Business, reported 2017-11-29, distributed in CA, GA, IL, MI, MN, MO. During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount
| Recall number | Z-0114-2018 |
|---|---|
| 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 | 2017-10-17 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-11-03 |
| Distributed | CA, GA, IL, MI, MN, MO |
| Countries outside the US | CA, CH |
| Lot numbers | 17230, 17233, 17234, 17241, 2020 |
| Model numbers | 360, 36000 |
Product
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
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.
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-0114-2018. 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.