CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

CS100 IABP recalled by Datascope

Datascope is recalling CS100 IABP, distributed nationwide in the US. The recall was initiated on 23 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Model No; All UDI; All Serial No.

Quantity recalled10,897 units

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-1486-2026
FDA event ID: 98189
Recalling firm: Datascope, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 23 Jan 2026
FDA classified: 3 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

23 Jan 2026	Recall initiated by company
3 Mar 2026	Classified by FDA	+39 days
11 Mar 2026	Published in enforcement report	+8 days

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

Reason for recall

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

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

CS100 IABP. Software Version CS100 IABP Q.01.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.

Nationwide Georgia

Questions about this recall

Why was it recalled?

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Which lots are affected?

All Model No; All UDI; All Serial No.

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98189

This product is part of a recall event; the main page for the event is CS300 IABP recalled by Datascope.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026	CLASS II	CS300 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide

More recalls from Datascope

All 134

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS III	Battery Charging Station recalled by Datascope	Datascope	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	CS300 IABP recalled by Datascope	Datascope	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide
24 Dec 2025Device	CLASS III	Cardiosave Rescue recalled by Datascope	Datascope	Other	Nationwide
17 Dec 2025Device	CLASS II	Cardiosave Hybrid recalled by Datascope	Datascope	Other	Nationwide

Other Medical Software recalls

All 932

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide