Edermy recalls all PIE Trolley System Model 2005 units due to lack of 510K clearance. This may cause safety issues during use. Consumers should contact Edermy for details.
Lack of 510K clearance
Edermy is recalling all PIE Trolley System Model 2:005 units because they lack proper 510K clearance. This could lead to safety risks during normal use.
The lack of 510K clearance means the trolley system may not meet safety standards. This could lead to potential safety issues during normal use.
All owners of the PIE Trolley System Model 2005 are affected. Users who operate this system are at risk.
Check for the PIE Trolley System Model 2005 label on the product. All lots of this model are included in the recall.
Reach out to Edermy for specific recall instructions and assistance.
The recall states there is a lack of 510K clearance, which may cause safety issues, but the exact risk level is not specified.
Check for the PIE Trolley System Model 2005 label on the product. All lots of this model are included in the recall.
Contact Edermy for specific recall instructions and assistance.
We’ve drafted a message you can send Edermy to request your refund or repair — edit it as you like.
Subject: Recall Z-1461-2026 — Edermy Edermy Hello, I own a Edermy that is covered by recall Z-1461-2026 from Edermy. 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.
