Edermy LLC Recalls PIE PAK Medical Devices Due to Lack of 510K Clearance
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Edermy LLC has issued a voluntary recall for 11,202 PIE PAK units because the devices lack the required FDA 510K clearance for distribution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Edermy LLC has initiated a voluntary recall of its PIE PAK medical devices. The recall was triggered because the products were distributed without the necessary 510K clearance from the U.S. Food and Drug Administration (FDA). The recall is currently classified as a Class II action.
Which Products Are Affected
The recall involves 11,202 units of the PIE PAK device. Affected models include:
- P2HC-A
- P2HC-S
- P2HC
All lots are included in this recall. The products were distributed nationwide in the following states: Ohio, Arizona, Illinois, Pennsylvania, Indiana, California, Missouri, Massachusetts, Minnesota, Virginia, Florida, New York, Alabama, South Carolina, North Carolina, Tennessee, Texas, and Colorado.
What You Should Do
Edermy LLC began notifying affected customers via e-mail on January 14, 2026. Consumers or healthcare facilities in possession of these models should follow the instructions provided in the firm's notification. For additional information regarding the return or status of these devices, parties may contact Edermy LLC at their Pendergrass, Georgia facility located at 115 Enterprise Dr Ste A.
Why This Matters
FDA 510K clearance is a regulatory requirement that ensures a medical device is safe and effective for its intended use. Distributing devices without this clearance means the products have not undergone the necessary regulatory review to verify their safety profiles.
Source
Information provided by the FDA under Recall Number Z-1462-2026.
Original source: FDA Official Notice ↗
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