Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1587-2026 — Battery Charging Station; Model: 0998-00-0802;

U.S. FDA — Device Enforcement · United States · 2026-02-06 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1587-2026
Date of alert
2026-02-06
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Datascope Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10607567111964
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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