Tyvaso Inhalation System Patient a) Starter Kit with TYVASO — Class III drug recall D-1188-2018
Terminated recall by United Therapeutics Corp., reported 2018-09-19, distributed in IL, PA. Defective Delivery System: Water ingress through the lower water cup sensor of the device.
| Recall number | D-1188-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Therapeutics Corp., Durham, NC, United States |
| Recall initiated | 2018-08-14 |
| Classified | 2018-09-12 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-10-30 |
| Distributed | IL, PA |
| Quantity | 2,801 devices |
| NDC | 66302-0206, 66302-0206-01, 66302-0206-02, 66302-0206-03, 66302-0206-04 |
| Lot numbers | 2101504, 2101509, 2101522, 2101531, 2101534, 2101543, 2101558 |
| Expiration dates | 2019-07-31, 2019-11-30, 2021-04-24, 2021-05-08, 2021-05-15, 2021-06-10, 2021-06-14, 2021-07-26 |
Product
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Reason for recall
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1188-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.