Newport HT70 Ventilator — Class I medical device recall Z-1915-2025
Ongoing recall by Covidien, reported 2025-06-18, distributed nationwide. Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in
| Recall number | Z-1915-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Carlsbad, CA, United States |
| Recall initiated | 2025-05-21 |
| Classified | 2025-06-09 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DO, EE, EG, ES, FR, GB, GR, GT, GY, HR, HU, ID, IL, IN, IR, IT, JM, JO, JP, KE, KR, LB, LK, LT, MX, MY, NG, NL, NO, OM, PA, PE, PH, PK, PL, PT, QA, RO, SA, SG, SI, SK, TH, TN, TR, TT, UA, UY, VN, ZA |
| Quantity | 5,394 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00839935008221, 00839935009457, 04987742321180, 04987742326161, 04987742372618, 10884521197855, 10884521208940, 10884521542044, 10884521542051, 10884521542082, 10884521542105, 10884521542136, 10884521542143, 10884521542174, 10884521542181, 10884521542204, 10884521542228, 10884521542242, 10884521542259, 10884521542266, 10884521542273, 10884521544178, 10884521544291, 10884521544307, 10884521544338 and 3 more |
| Serial numbers | 10884521542181/HT7P190131, 10884521542204/HT7P180658, 10884521542228/HT7P150096, 10884521544291/HT7P150048, 10884521544369, HT70PM-ES-EU/10884521542174, HT70PM-ES-NA/10884521544307, HT70PM-PT-BR/10884521544338, HT70PM-SY-EU/10884521542174, HT72160002, HT72160004, HT72160005, HT72160007, HT72160011, HT72160012, HT72160017, HT72160020, HT72160023, HT72160025, HT7P150179, HT7P150184, HT7P150198, HT7P150236, HT7P150296, HT7P150300 and 475 more |
| Model numbers | DLHT70PM-WW-NA, GR-PCB3252A, GR105795, GR105796, GRFSKHT70M-2, HT70, HT70-2, HT70-SY-EU, HT70M-CN-NA, HT70M-ES-EU, HT70M-JP-NA, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70P, HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, HT70PM-SY-EU, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU and 2 more |
Product
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WW-NA. HT70-2 CONTROL BOARD ROHS, REF: GR-PCB3252A. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.
Reason for recall
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
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-1915-2025. 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.