CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report

PIE PAK recalled by Edermy

Edermy is recalling PIE PAK, distributed nationwide in the US. The recall was initiated on 14 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots UDI:

Quantity recalled11202 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1462-2026
FDA event ID: 98303
Recalling firm: Edermy, Pendergrass, GA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jan 2026
FDA classified: 24 Feb 2026
Reported: 4 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jan 2026	Recall initiated by company
24 Feb 2026	Classified by FDA	+41 days
4 Mar 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of 510K clearance

Product as listed by the FDA

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Florida Illinois Indiana Massachusetts Minnesota Missouri North Carolina New York Pennsylvania South Carolina Tennessee Texas Virginia

Questions about this recall

Is PIE PAK recalled?

Yes. Edermy recalled PIE PAK on 14 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1462-2026.

Why was it recalled?

Lack of 510K clearance

Which lots are affected?

All Lots UDI:

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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