FDA Device recall Z-0932-2026
Cardiosave Rescue
- FDA Device
- Class III
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class III recall of Cardiosave Rescue by Datascope, citing the IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0932-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-10-23 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Rescue
Reason
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Identifiers
| code_info | Model: 0998-00-0800-83; UDI-DI: 10607567108407; Serial Numbers: All; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0932-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.