United Therapeutics Recalls Tyvaso Inhalation System Due to Water Ingress Risk
United Therapeutics recalls Tyvaso inhalation system starter kits with water ingress risk. Defective device may cause improper medication delivery. Consumers should contact for remedy.
Lower-risk recall
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Contact the company
What happened, in plain English
United Therapeutics is recalling Tyvaso inhalation system starter kits because water can enter the device through the lower water cup sensor. This defect may lead to improper medication delivery, which could affect treatment effectiveness. Read more at govinfonow.com/recall/39734-united-therapeutics-recalls-tyvaso-inhalation-system-due-to-water-ingress.
Source Summary by GovInfoNow · govinfonow.com/recall/39734-united-therapeutics-recalls-tyvaso-inhalation-system-due-to-water-ingress · Updated October 6, 2026 · FDA enforcement record: FDA #D-1188-2018
Cite this page
“United Therapeutics Recalls Tyvaso Inhalation System Due to Water Ingress Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39734-united-therapeutics-recalls-tyvaso-inhalation-system-due-to-water-ingress. Based on FDA recall #D-1188-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1188-2018%22&limit=1).
Why it’s dangerous
Water entering the lower water cup sensor can disrupt the device's ability to deliver medication properly. This may cause inconsistent dosing or ineffective treatment of the condition.
Who’s affected
Patients using the Tyvaso inhalation system starter kits with the specified lot numbers are affected. Those with respiratory conditions requiring this medication are at higher risk.
How to tell if you have this one
Check the lot numbers on the device: 2101503, 2101507, 2101523, 2101532, 2101533, 2101557, 2101558, or 2101504, 2101509, 2101522, 2101531, 2101534, 2101543, 2101558. The product was sold with expiration dates up to July 2021.
- Brand
United Therapeutics- Category
Drug
What to do — step by step
Check Device Lot Numbers
Identify the lot numbers on the device: 2101503, 2101507, 2101523, 2101532, 2101533, 2101557, 2101558, or 2101504, 2101509, 2101522, 2101531, 2101534, 2101543, 2101558.
Where it went and when
Where it was distributed
Distributed in Illinois and Pennsylvania.
FDA distribution: “IL, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Pennsylvania.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1188-2018 (August 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1188-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.