Medical device recalls

Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;

Recall date
February 6, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1587-2026
FDA classification
Class III
Brand / firm
Datascope Corp.
Sold / distributed
Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.

Why it was recalled

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Battery Charging Station; Model: 0998-00-0802;

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