Summary
The FDA issued a Class II for PIE PAK Models: P2HC-A, P2HC-S, P2HC by Edermy LLC. Reason: Lack of 510K clearance.
Details
Source
Device Recall
External ID
Z-1462-2026
Action Date
2026-03-04
Status
Ongoing
Category
device
Product Description
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lot/Code Info: All Lots UDI:
Quantity Affected: 11202 units
Reason for Recall
Lack of 510K clearance
Distribution
US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-14
Company
Pendergrass, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Edermy LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edermy LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edermy LLC have FDA actions?
Edermy LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1462-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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