Tyvaso (United Therapeutics) – Defective Delivery System (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Brand
United Therapeutics Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887 TD-100 S/N's 23103982 23103985 23103988 23103990 23103992 23103984 23103986 23103989 23103991 23103993 23103959 23103961 23103963 23103994 23103958 23103960 23103962 23103972 Kit S/N 1888 1889 1890 1891 1892 1893 1899 1900 1901 TD-100 S/N's 23103970 23103997 23103996 23104022 23104019 23103975 23103998 23103999 23104024 23104020 23104014 23103981 23103980 23103974 23104013 23103978 23103973 23103964 Kit S/N 1902 1903 1904 1905 1906 1907 1908 1909 1910 TD-100 S/N's 23103966 23103968 23103956 23103952 23103950 23103967 23103977 23103957 23103955 23103951 23103948 23103945 23103941 23103943 23103942 23103940 23103944 Kit S/N 1911 1912 1913 1914 1916 1917 1918 1919 1921 TD-100 S/N's 23103947 23103949 23103939 23103946 23104001 23103965 23103969 23104002 23104005 23104003 23104011 23104007 23104008 TD-100 devices shipped to Accredo (continued): Kit S/N 1922 1923 1933 1934 TD-100 S/N's 23104012 23104009 23103937 23103938 23104025 23104010 Kit S/N 1935 1939 2175 2176 2178 2212 2227 2228 TD-100 S/N's 23104030 23104027 23101851 23103987 23103971 23104028 23103700 23103608 23103979 23103334 23103439 23101566 23103672 Kit S/N 2229 2311 2364 2481 2491 TD-100 S/N's 23103686 23103684 23104026 23104029 23104004 Optineb devices shipped to Accredo: Kit S/N 3658 3659 3661 3669 3670 3672 3674 3675 3680 Optineb S/N's 20900203 20900205 20900210 20900228 20900230 20900204 20900206 20900211 20900229 20900231 20900235 20900223 20900239 20900252 20900236 20900202 20900224 20900250 Kit S/N 3681 3682 3687 3694 3696 3702 3703 3704 Optineb S/N's 20900249 20900311 20900298 20900256 20900260 20900254 20900312 20900300 20900257 20900261 20900273 20900275 20900277 20900272 20900274 20900276 Optineb devices shipped to Curascript: Kit S/N 3657 3666 3671 3673 3677 3679 3685 3686 3689 Optineb S/N's 20900200 20900220 20900232 20900237 20900242 20900201 20900221 20900234 20900238 20900243 20900247 20900305 20900302 20900297 20900246 20900304 20900301 20900296 Kit S/N 3693 3701 3706 3709 Optineb S/N's 20900255 20900269 20900281 20900313 20900282 20900270 20900287 20900314
United Therapeutics Corp. is recalling Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Ora due to Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, TX
Page updated: Jan 10, 2026