Genesee BioMedical recalls sternal valve retractors with atrial and aortic rakes (models SRCL-1, SRCL-AR, etc.) due to corrosion in retractor blades that may weaken welds and cause bearing failure during cardiac surgery.
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.
Genesee BioMedical is recalling sternal valve retractors with atrial and aortic rakes because corrosion in the blade can weaken the welded joint, potentially causing the bearing to break during cardiac surgery. This poses a risk of equipment failure during critical procedures.
Corrosion forms in the area where the bearing/button meets the blade body, weakening the welded joint. This can cause the bearing/button to break during use, potentially leading to equipment failure during cardiac surgery.
Cardiac surgery patients and medical professionals using the recalled sternal valve retractors. The risk is highest for those using the specific models with serial numbers listed in the recall.
Check for the models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1, and CSR-AR. The recall includes specific serial numbers listed in the notice for these models.
Verify if your device has a serial number from the list provided in the recall notice.
The recall is due to corrosion in the retractor blade that can weaken the welded joint and cause the bearing/button to break during cardiac surgery.
The affected models are SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1, and CSR-AR.
Check the serial number against the list provided in the recall notice, which includes specific numbers for the affected models.
We’ve drafted a message you can send Genesee BioMedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1953-2018 — Genesee BioMedical Genesee BioMedical Hello, I own a Genesee BioMedical that is covered by recall Z-1953-2018 from Genesee BioMedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
