FDA Device recall Z-1915-2025
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. Newpor…
- FDA Device
- Class I
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class I recall of 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. Newpor… by Covidien, citing 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 us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1915-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-21 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Covidien |
| Distribution | US |
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-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.
Reason
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.
Identifiers
| code_info | REF/UDI-DI/Serial Numbers: HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159,…REF/UDI-DI/Serial Numbers: HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159, N10HT700710161, N10HT700710162, N10HT700710163, N10HT700710164, N10HT700810194, N10HT700810199, N10HT700810202, N10HT700810204, N10HT700810205, N10HT700810206, N10HT700910223, N10HT700910227, N10HT701010279, N10HT701011015, N10HT701011016, N10HT701111044, N10HT701111048, N10HT701111049, N10HT701111050, N11HT700111137, N11HT700111139, N11HT700111141, N11HT700111142, N11HT700111143, N11HT700111144, N11HT700211145, N11HT700211155, N11HT700211160, N11HT700211161, N11HT700211163, N11HT700211164, N11HT700311168, N11HT700311169, N11HT700311170, N11HT700311183, N11HT700311184, N11HT700311185, N11HT700311186, N11HT700311188, N11HT700311189, N11HT700311191, N11HT700311192, N11HT700311193, N11HT700311195, N11HT700311196, N11HT700311197, N11HT700311201, N11HT700311202, N11HT700311203, N11HT700311204, N11HT700311207, N11HT700311208, N11HT700311209, N11HT700311233, N11HT700311234, N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1915-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.