Merit Medical recalls CorVocet Biopsy Systems with specific catalog codes due to misaligned components that may cause needle ejection outside the body, leading to needle stick injuries.
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
Merit Medical is recalling several models of CorVocet Biopsy Systems because manufacturing issues can cause needles to eject outside the body, potentially causing needle stick injuries. Affected units include specific catalog codes and lot numbers listed in the recall notice.
The biopsy systems have components that are misaligned due to manufacturing assembly equipment issues. This misalignment can cause the needle to eject when triggered outside the body, potentially leading to needle stick injuries for users or patients.
Users of the CorVocet Biopsy System who own the affected catalog codes and lot numbers are at risk. Healthcare professionals and patients using these devices for biopsies may face needle stick injuries if the system malfunctions.
Check if your CorVocet Biopsy System has catalog codes listed in the recall notice, such as CORA1610/B, CORA1610S/B, or other specific models. Also, verify the lot numbers or UDI codes provided in the recall details.
Review the catalog codes and lot numbers listed in the recall notice to confirm if your device is affected.
Reach out to Merit Medical Systems for further assistance or to confirm if your specific model is included in the recall.
The recall includes CorVocet Biopsy Systems with specific catalog codes such as CORA1610/B, CORA1610S/B, CORA1615/B, and other models listed in the recall notice.
Check the catalog code and lot number on your device against the list of affected models and lot numbers provided in the recall notice.
Contact Merit Medical Systems to confirm if your device is affected and follow their instructions for next steps.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0137-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0137-2023 from Merit Medical. 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.
