Use caution Medical device recall · FDA · Published April 30, 2020

Covidien Foley Catheter with Temperature Sensor: Risk of Incorrect Temperature Readings

Covidien recalls 16FR silicone coated foley catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and inadequate treatment. Affected units were sold with specific product codes and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1985-2020Medical device Covidien ›

Use caution until it’s fixed

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Take action

Contact the company

Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113

✎ GovInfoNow plain-language explainer

Covidien is recalling a specific type of urinary catheter that includes a temperature sensor. The device may not measure body temperature accurately, which could lead to wrong diagnoses or improper treatment. This is a serious issue for patients needing precise temperature monitoring. Read more at govinfonow.com/recall/65262-covidien-foley-catheter-with-temperature-sensor-risk-of-incorrect-temperature.

Source Summary by GovInfoNow · govinfonow.com/recall/65262-covidien-foley-catheter-with-temperature-sensor-risk-of-incorrect-temperature · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1985-2020

Cite this page

“Covidien Foley Catheter with Temperature Sensor: Risk of Incorrect Temperature Readings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65262-covidien-foley-catheter-with-temperature-sensor-risk-of-incorrect-temperature. Based on FDA recall #Z-1985-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1985-2020%22&limit=1).

The FDA announced on April 30, 2020, that Covidien LLC voluntarily recalled the Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor. The device failed to meet calibrated temperature sensing tolerances, potentially leading to incorrect diagnoses and insufficient treatment.

How to tell if you have it

Brand: Covidien
Product: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor
Size/Code: 16FR 5CCCC2W
Product Code: 50516ICT
Lot Number: 1909500464
Quantity: 480 units

The hazard

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Recent brand recalls include the EndoFLIP System recall on May 13, 2026, and the Mon-a-Therm Stethoscope Recall on April 23, 2026. Other recent recalls of similar products include the Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (November 6, 2025), the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and the Getinge Thoracic Catheter Recall (August 7, 2026).

How to tell if you have this one

Check for the product code 50516ICT and lot number 1909500464 on the catheter packaging. This specific model was sold for urinary drainage with temperature monitoring.

Brand
Covidien
Category
Medical device

FDA recall event · 11 products

All 11 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
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1984-2020	Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Number: 1910100464	468 units
Z-1985-2020	Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Number: 1909500464	480 units
Z-1986-2020	Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1908700664, 1918351164	3012 units
Z-1987-2020	Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1914135864	0
Z-1988-2020	Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1909308464, 1933000164	3470 units
Z-1989-2020	Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1909308664, 1909320964 1933802964	8162 units
Z-1990-2020	Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1826714264, 1908533364, 1909302964, 1909303064, 1910654864, 1911300664, 1916240464, 1921106564, 1922533864, 2004908564, 2005617264, 2006339564	23587 units
Z-1991-2020	Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1828205964, 1911414164	46828 units
Z-1992-2020	Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1828206564, 1828813264 1829618264, 1829618364 1831001964, 1906506564 1907134164, 1909308864 1919705064, 1921106664 2000723764, 2003520164 2005617664	46828 units
Z-1993-2020	Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1919708264	120 units
Z-1994-2020	Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.; Lot Numbers: 1914133564	0

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product code 50516ICT and lot number 1909500464 on the catheter packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

Apr 30, 2020Firm started the recall
May 14, 2020FDA classified it Class II
May 20, 2020Published in FDA’s Enforcement Report
Dec 14, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/65262-covidien-foley-catheter-with-temperature-sensor-risk-of-incorrect-temperature">Covidien Foley Catheter with Temperature Sensor: Risk of Incorrect Temperature Readings (GovInfoNow)</a>

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-1985-2020 (April 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1985-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.