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Open, Classified

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

FDA Recall Z-1462-2026 · Posted 2026-02-24

Recalling FirmEdermy LLC
Recall StatusOpen, Classified
Product CodeKPL
Date Initiated2026-01-14
Product Quantity11202 units

Reason for Recall

Lack of 510K clearance

Firm Action

On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consignees via mail. PieMed asked consignees to take the following actions: 1. Discontinue use of the PIE 2005 Trolley System and PIE PAK Components. 2. Secure and retain the PIE 2005 Trolley System and any unused PIE PAK kits in a controlled location to prevent further use. 3. Consult with a healthcare provider regarding continuation of care and alternative treatment options, as appropriate. 4. You may complete acknowledgement and receipt form in 2 weeks. 5. Please ensure this notification is provided to all affected individuals. If the device has been transferred to a different location, please ensure they are provided with a copy of the communication. 6. No further action should be taken with the affected device(s) unless directed by PIEMed.

Root Cause

No Marketing Application

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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