Datascope Corp. recalls Cardiosave Rescue
- Recall date
- October 23, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0932-2026
- FDA classification
- Class III
- Brand / firm
- Datascope Corp.
- Sold / distributed
- 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¿…
Why it was recalled
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Cardiosave Rescue
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