Class II — Genesee BioMedical, Inc.
| Recalling firm | GENESEE BIOMEDICAL, INC. |
|---|---|
| Registered facility | GENESEE BIOMEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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. |
| Quantity | 444 units |
| Distribution | Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom |
| Initiated | 2018-02-26 |
| Classified | 2018-05-29 |
| Recall number | Z-1953-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Genesee BioMedical, Inc. (Z-1953-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80024/
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