SynCardia 50cc TAH-t — Class II medical device recall Z-0126-2024
Completed recall by SynCardia Systems LLC, reported 2023-11-01, distributed in AZ, CA, FL, IL, IN, NC, NE, NY…. Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
| Recall number | Z-0126-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | SynCardia Systems LLC, Tucson, AZ, United States |
| Recall initiated | 2023-08-01 |
| Classified | 2023-10-20 |
| Reported by FDA | 2023-11-01 |
| Distributed | AZ, CA, FL, IL, IN, NC, NE, NY, OH, OK, PA, TX, VA, WA, WI |
| Countries outside the US | AT, AU, CA, DE, FR, GB, IT, KW, LT, RS, SA, SI, TR |
| Quantity | 114 units |
| UPC / GTIN / UDI-DI | 00858000003053 |
| Model numbers | 570500 |
Product
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason for recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
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-0126-2024. 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.