Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.

Recall date

January 23, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1487-2026

FDA classification

Class II

Brand / firm

Datascope Corp.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Cze…

Why it was recalled

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CS300 IABP. Software Version CS300 IABP C.01.