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Edermy LLC FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PIE PAK Models: P2HC-A, P2HC-S, P2HCClass IIJan 14, 2026Lack of 510K clearance |
| PIE Trolley System Model: 2005Class IIJan 14, 2026Lack of 510K clearance |