The Recall Desk
HighFDA (Devices)·Z-1915-2025·Announced 2025-06-18

[pending] Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M

Pending LLM rewrite. Source: FDA_DEVICE Z-1915-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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-
Manufacturer
Covidien
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

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