# FDA recall Z-1953-2018

> **Genesee BioMedical, Inc.** · Class II · device recall initiated 2018-02-26.

## 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.

## 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

## Key facts

- **Recall number:** Z-1953-2018
- **Recalling firm:** Genesee BioMedical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-02-26
- **Report date:** 2018-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denver, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1953-2018

## Citation

> AI Analytics. FDA recall Z-1953-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1953-2018. Source: US FDA. Licensed CC0.

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