Z-0916-2026 Class II Ongoing
FDA device recall Z-0916-2026 was initiated by Datascope Corp. on November 4, 2025 and is designated Class II. Reason for recall: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. The recall status is ongoing. Affected quantity: 11,470 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,470 units
Product Description
Reason for Recall
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.