“Datascope Cardiosave Rescue Recall: IFU Addendum Updates Vibration Table Standards.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51021-datascope-cardiosave-rescue-recall-ifu-addendum-updates-vibration-table-standards. Based on FDA recall #Z-0932-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0932-2026%22&limit=1).
The FDA announced on Oct. 23, 2025, that Datascope Corp. is voluntarily recalling Cardiosave Rescue devices because the Instructions for Use addendum updates the Vibration and Shock Table to reference correct standards. Owners should contact the company for remedy details.
How to tell if you have it
Brand: Datascope
Product: Cardiosave Rescue
Model: 0998-00-0800-83
UDI-DI: 10607567108407
Serial Numbers: All
Quantity: 47 units
The hazard
The recall addresses an issue where the Instructions for Use addendum updates the Vibration and Shock Table to reference the correct standards, according to the FDA.
Context
GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), Philips Azurion 7 B20 System Recall (Jan. 26, 2026), and Katalyst DEX Ophthalmic Forceps Recall (March 25, 2026).
How to tell if you have this one
Check for the model number 0998-00-0800-83 on your Cardiosave Rescue device. All units produced are affected by this recall.
Brand
Datascope
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Ongoing
Distribution
Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), 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, Republic Of China, Tanzania, United Republic Of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia;
Recall number
Product, codes & lots
Quantity
Z-0931-2026
Cardiosave Hybrid; 1) Model: 0998-00-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 2) Model: 0998-00-0800-32; UDI-DI: 10607567111117; Serial Numbers: All; 3) Model: 0998-00-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 4)Model: 0998-00-0800-35; UDI-DI: 10607567109107; Serial Numbers: All; 5)Model: 0998-00-0800-36; UDI-DI: 10607567114187; Serial Numbers: All; 6)Model: 0998-00-0800-45; UDI-DI: 10607567108421; Serial Numbers: All; 7)Model: 0998-00-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 8)Model: 0998-00-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 9) Model: 0998-00-0800-55; UDI-DI: 10607567108414; Serial Numbers: All; 10) Model: 0998-00-0800-65; UDI-DI: 10607567113432; Serial Numbers: All; 11) Model: 0998-UC-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 12) Model: 0998-UC-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 13) Model: 0998-UC-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 14) Model: 0998-UC-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 15) Model: 0998-UC-0800-55; UDI-DI: 10607567108414; Serial Numbers: All;
11470 units (5095 US, 6375 OUS)
Z-0932-2026
Cardiosave Rescue; Model: 0998-00-0800-83; UDI-DI: 10607567108407; Serial Numbers: All;
47 units (44 US, 3 OUS)
Based on the official FDA remedy
What to do — step by step
Review User Manual
Check the IFU addendum for updated vibration and shock table standards.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0932-2026 (October 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0932-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.