CLASS III ONGOING Device recall · Reported 25 Mar 2026 · FDA Enforcement Report

Battery Charging Station recalled by Datascope

Datascope is recalling Battery Charging Station, distributed nationwide in the US. The recall was initiated on 6 Feb 2026 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel: 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;

Quantity recalled28 units (20 US, 8 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1587-2026
FDA event ID: 98432
Recalling firm: Datascope, Mahwah, NJ
Classification: Class III
Status: Ongoing
Recall initiated: 6 Feb 2026
FDA classified: 19 Mar 2026
Reported: 25 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

6 Feb 2026	Recall initiated by company
19 Mar 2026	Classified by FDA	+41 days
25 Mar 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was 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.

Nationwide District of Columbia Florida Georgia Illinois Indiana Maryland Michigan North Carolina Texas Washington Wisconsin

Questions about this recall

Is Battery Charging Station recalled?

Yes. Datascope recalled Battery Charging Station on 6 Feb 2026. The recall is Class III and its status is Ongoing. Recall number Z-1587-2026.

Why was it recalled?

Which lots are 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;

Where was it 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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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17 Dec 2025Device	CLASS II	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide

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