Data Foundry

Medical device recalls 2026

Philips Respironics Trilogy Evo Universal — Class I medical device recall Z-1617-2026

Ongoing recall by Philips Respironics, Inc., reported 2026-04-01, distributed nationwide. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the s

Recall numberZ-1617-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2026-03-02
Classified2026-03-26
Reported by FDA2026-04-01
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VN, ZA
Quantity113,717

Product

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Reason for recall

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

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/Z-1617-2026. 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.