FDAApril 30, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
covidien
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACovidien Mon-a-Therm General Purpose Temperature Probe REF: 900442026-04-23
- FDACovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 900502026-04-23
- FDACovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 900422026-04-23
- FDACovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;2026-04-15
- FDACOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, L...2026-04-15
- FDAHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product N...2026-01-30
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;2025-09-25
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;2025-09-25
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