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United Therapeutics Corp.

United Therapeutics Corp. Recalls

All product recalls associated with United Therapeutics Corp..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Aug 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

Tyvaso Inhalation System (United Therapeutics) – Defective Device (2018)

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Class IIILow

FDAAug 14, 2018IL, PA• United Therapeutics Corp.

TYVASO Inhalation Solution (United Therapeutics) – Manufacturing Deviation (2017)

CGMP Deviations

Class IIModerate

FDASep 11, 2017PA• United Therapeutics Corp.

Tyvaso (United Therapeutics) – Defective Delivery System (2014)

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Class IIModerate

FDAMar 28, 2014FL, TX• United Therapeutics Corp.