Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.
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 is classified as FDA Class II. The hazard involves a risk of incorrect diagnosis and insufficient treatment due to sensor failure, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 23,587 units of Dover 400mL, 100% Silicone Premium Urine Meter Foley Trays. The affected products are sterile, prescription-only medical devices used for urinary bladder drainage and simultaneous temperature monitoring. The recall involves specific lot numbers distributed nationwide in the United States.
The recall was initiated because the temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2°C. This defect means the devices may not correctly measure patient body temperatures. The FDA notes that failure to correctly measure body temperatures could lead to an incorrect diagnosis and insufficient treatment.
Healthcare providers and facilities should stop using the affected lots immediately. Patients who have used these devices should consult their healthcare provider if they have concerns regarding their temperature readings or diagnosis. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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 U
- Manufacturer
- Covidien Llc
- Affected units
- 23,587
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 (12)
- Lot Numbers: 1826714264
- 1908533364
- 1909302964
- 1909303064
- 1910654864
- 1911300664
- 1916240464
- 1921106564
- 1922533864
- 2004908564
- 2005617264
- 2006339564
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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