Covidien Llc: Medical Device Recall in 2020 - (Recall #: Z-1984-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: May 20, 2020

Recall Number: Z-1984-2020

Event ID: 85629

Reason for Recall:

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

Status: Terminated

Product Quantity: 468 units

Code Information:

Lot Number: 1910100464

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated