Cardiosave Rescue — Class III medical device recall Z-0932-2026
Ongoing recall by Datascope Corp., reported 2025-12-24, distributed nationwide. The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
| Recall number | Z-0932-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2025-10-23 |
| Classified | 2025-12-16 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 10607567108407 |
| Model numbers | 0998-00-0800-83 |
Product
Cardiosave Rescue
Reason for recall
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0932-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.