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Lower risk Medical device recall · FDA · Published July 11, 2018

Covidien P40: Temperature Sensor Defective, May Show Lower Body Temp

Covidien recalls P400 PREM U/M 18FR TMPSNS with defective temperature sensors that may show lower body temperature than actual. Affected units have item code P4P18TS.

🇺🇸 FDA recall #Z-3207-2018Medical deviceCovidien ›
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Contact the company

Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer

Covidien is recalling temperature sensors for medical use that may show lower body temperature readings than actual. This could lead to incorrect medical decisions if the device is used in patient monitoring. Read more at govinfonow.com/recall/70640-covidien-p40-temperature-sensor-defective-may-show-lower-body-temp.

Source Summary by GovInfoNow · govinfonow.com/recall/70640-covidien-p40-temperature-sensor-defective-may-show-lower-body-temp · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3207-2018

Cite this page

“Covidien P40: Temperature Sensor Defective, May Show Lower Body Temp.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70640-covidien-p40-temperature-sensor-defective-may-show-lower-body-temp. Based on FDA recall #Z-3207-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3207-2018%22&limit=1).

The FDA announced on July 11, 2018, that Covidien LLC voluntarily recalled P400 PREM U/M 18FR TMPSNS temperature sensor catheters. The devices may display lower body temperature readings than the patient's actual temperature.

How to tell if you have it

  • Brand: Covidien
  • Product: P400 PREM U/M 18FR TMPSNS
  • Item Code: P4P18TS
  • Lot Code: 1813600164

The hazard

The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls include the Covidien EndoFLIP System recall dated May 13, 2026, and the Covidien Mon-a-Therm Temperature Probe Recall dated April 23, 2026.

How to tell if you have this one

Check for the item code P4P18TS on the sensor packaging or label. The product is sold under the brand name Covidien and model P400 PREM U/M 18FR TMPSNS.

  • Brand
    Covidien
  • Category
    Medical device
FDA recall event · 6 products

All 6 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
    The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
Recall numberProduct, codes & lots
Z-3203-2018400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD; 1724157464,1726253464, 1730452764,1800353664, 1732650264,1733152664, 1800353664,1801652764, 1804350264
Z-3204-2018TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T; 1733850164 1805050064
Z-3205-2018400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD; 1733152764 1806451564
Z-3206-2018400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD; 1733952664 1735258064
Z-3207-2018P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS; 1813600164
Z-3208-2018P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS; 1814906864
Based on the official FDA remedy

What to do — step by step

  1. Check Sensor Label

    Look for the item code P4P18TS on the sensor packaging or label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 24 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jul 11, 201812. FDA classified it Class II: Sep 20, 201823. Published in FDA’s Enforcement Report: Sep 26, 201834. FDA terminated the recall: Aug 3, 2020420182020
  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

Is there a risk of serious injury?

The recall is for potential inaccurate temperature readings, not a direct risk of serious injury.

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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-3207-2018 (July 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3207-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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