Edermy LLC: Medical Device Recall in 2026 - (Recall #: Z-1462-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 14, 2026

Date Posted: March 4, 2026

Recall Number: Z-1462-2026

Event ID: 98303

Reason for Recall:

Lack of 510K clearance

Status: Ongoing

Product Quantity: 11202 units

Code Information:

All Lots UDI:

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated