Edermy LLC is recalling approximately 11,229 units of its PIE Trolley System and PIE PAK medical devices because they were distributed without required 510(k) clearance from the FDA. The recall affects 27 PIE Trolley Systems (Model 2005) and 11,202 PIE PAKs (Models P2HC-A, P2HC-S, and P2HC). Because these devices have not undergone the standard FDA review process for safety and effectiveness, their performance cannot be guaranteed.
The lack of 510(k) clearance means the safety and effectiveness of these devices have not been established by the FDA, potentially leading to unpredictable device performance during medical use.
Recall #: Z-1461-2026; Quantity: 27 units
Recall #: Z-1462-2026; Quantity: 11202 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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