Datascope Corp.: Medical Device Recall in 2026 - (Recall #: Z-1486-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

CS100 IABP. Software Version CS100 IABP Q.01.

Product Classification:

Class II

Date Initiated: January 23, 2026

Date Posted: March 11, 2026

Recall Number: Z-1486-2026

Event ID: 98189

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.

Status: Ongoing

Product Quantity: 10,897 units

Code Information:

All Model No; All UDI; All Serial No.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated