Sternal Valve Retractors With Atrial and Aortic Rakes — Class II medical device recall Z-1953-2018
Ongoing recall by Genesee BioMedical, Inc., reported 2018-06-06, distributed nationwide. Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the bla
| Recall number | Z-1953-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genesee BioMedical, Inc., Denver, CO, United States |
| Recall initiated | 2018-02-26 |
| Classified | 2018-05-29 |
| Reported by FDA | 2018-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CR, EG, GB, IL, IT, JP, KR, NL, NO, NZ, SE, TW, ZA |
| Quantity | 444 units |
| Reason classes | device malfunction |
| Serial numbers | 1000, 1001, 1002, 1003, 1004, 1006, 1007, 1019, 1021, 1022, 1024, 1025, 1026, 1027, 1028, 1034, 1035, 1036, 1037, 1038, 1039, 1040, 1044, 1045, 1046 and 419 more |
| Model numbers | ATR-1, CSR-1, SRCL-1, SRLP-1 |
Product
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Reason for recall
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
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-1953-2018. 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.