CS300 IABP — Class II medical device recall Z-1487-2026
Ongoing recall by Datascope Corp., reported 2026-03-11, distributed nationwide. The firm has identified that the battery runtime and cycle specifications contained in the devices Instruction
| Recall number | Z-1487-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2026-01-23 |
| Classified | 2026-03-03 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BB, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, GH, GR, GT, GY, HK, HN, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 10,897 units |
| Serial numbers | CS300 |
Product
CS300 IABP. Software Version CS300 IABP C.01.
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.
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-1487-2026. 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.