# FDA recall Z-1915-2025

> **Covidien** · Class I · device recall initiated 2025-05-21.

## 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 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA,  CA,  MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, 

## Key facts

- **Recall number:** Z-1915-2025
- **Recalling firm:** Covidien
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1915-2025

## Citation

> AI Analytics. FDA recall Z-1915-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1915-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*