Battery Charging Station recall (Datascope Corp.)
Medical deviceClass IIIOngoing
Summary: Datascope Corp. is recalling Battery Charging Station; Model: 0998-00-0802;. Reason: 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.
What is being recalled
Battery Charging Station; Model: 0998-00-0802;
Why
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.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
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. (states named: District of Columbia, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, North Carolina, Texas, Washington, Wisconsin)
How to tell if yours is affected
Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1587-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | February 6, 2026 |
| Reported | March 25, 2026 |
| Company | Datascope Corp. |
| Company location | Mahwah, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 28 units (20 US, 8 OUS) |
More recalls from Datascope Corp. · all medical device recalls · recalls from February 2026