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Datascope Corp. recalls Cardiosave Rescue

Recalled December 24, 2025 · FDA recall Z-0932-2026 · Datascope

Hazard
The IFU addendum updates the Vibration and Shock Table to reference the correct standards. · FDA Class III
Units
47 units (44 US, 3 OUS)
Sold at
Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;

Description

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Product
Cardiosave Rescue
Manufacturer(s)
Datascope Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Datascope Corp. recalls Cardiosave Rescue | RecallWatchUSA