FDA recall, , Low risk
Datascope Battery Charging Station
The Battery Charging Station has a protruding screw that prevents proper charging of certain batteries.
Summary by Recall Canary from the FDA notice
What happened
Datascope Corp., of Mahwah, New Jersey, recalled the Battery Charging Station because a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The 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. The recall began February 6, 2026, and was added to the FDA's Enforcement Report on March 19, 2026.
The recalled units were distributed worldwide, including in the United States in Florida, the District of Columbia, Georgia, Illinois, Indiana, Maryland, Michigan, North Carolina, Texas, Washington, and Wisconsin, and in Australia, Hong Kong, Israel, Japan, and Norway. The FDA classified the recall on March 19, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
0998-00-0802
- UDI-DI
- 10607567111964
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, District of Columbia, Georgia, Illinois, Indiana, Maryland, Michigan, North Carolina, Texas, Washington, Wisconsin and the countries of Australia, Hong Kong, Israel, Japan, Norway.
- Company
- Datascope Corp.Mahwah, New Jersey
- Hazard
- Device defect
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98432
- Recall number
- Z-1587-2026
- Quantity recalled
- 28 units (20 US, 8 OUS)
All recalls from Datascope Corp.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
