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Lower risk Medical device recall · FDA · Published October 17, 2017

3M Bair Hugger Normothermia Sensors May Show Low Temperatures

3M recalls Normothermia System temperature sensors that may show lower than actual patient temperatures. Affected units have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-0114-2018Medical device3M ›
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Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN 55144-0001
✎ GovInfoNow plain-language explainer

3M is recalling certain temperature sensors for the Bair Hugger Normothermia System because a programming error could cause them to show lower temperatures than a patient's actual temperature. This could lead to incorrect warming decisions during medical procedures. Read more at govinfonow.com/recall/72819-3m-bair-hugger-normothermia-sensors-may-show-low-temperatures.

Source Summary by GovInfoNow · govinfonow.com/recall/72819-3m-bair-hugger-normothermia-sensors-may-show-low-temperatures · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0114-2018

Cite this page

“3M Bair Hugger Normothermia Sensors May Show Low Temperatures.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72819-3m-bair-hugger-normothermia-sensors-may-show-low-temperatures. Based on FDA recall #Z-0114-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2018%22&limit=1).

The FDA announced on 2017-10-17 that 3M Company - Health Care Business is recalling 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000). The hazard involves a programming error causing lower-than-actual temperature readouts. This recall has been terminated.

How to tell if you have it

  • Brand: 3M
  • Product: 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
  • Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29
  • Quantity: 153 cases (3825 sensors)
  • Distribution: CA, MI, IL, MO, MN, GA, and Canada, Switzerland

The hazard

According to the FDA, a programming translation error could occur in a small amount of the sensors. This error leads to a temperature readout that is lower than the patient’s actual temperature.

Context

GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2024-08-14, including issues with Clarity Precision Grip Attachments and Tegaderm CHG Dressing contamination risk. Other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (2026-04-23) and Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (2026-05-28).

How to tell if you have this one

Check for the Model 360 sensors with lot numbers 17230 (exp. Aug 2020), 17233 (exp. Aug 2020), 17234 (exp. Aug 2020), or 17241 (exp. Aug 2020).

  • Brand
    3M
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Sensor Lot Number

    Look for the lot numbers 17230, 17233, 17234, or 17241 on the sensor packaging or label.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “CA, MI, IL, MO, MN, GA, and Canada, Switzerland” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Georgia, Illinois, Michigan, Minnesota, Missouri.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Oct 17, 201712. FDA classified it Class II: Nov 18, 201723. Published in FDA’s Enforcement Report: Nov 29, 201734. FDA terminated the recall: Nov 3, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using these sensors immediately?

No, the recall does not require immediate discontinuation. The sensors can be used with normal precautions.

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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-0114-2018 (October 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0114-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA