FDA Medical Device Recalls (openFDA)
Edermy LLC: PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Recall number
- Z-1462-2026
- Recalling firm
- Edermy LLC
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Status
- Open, Classified
- Initiated
- 2026-01-14
- Posted
- 2026-02-24
- Terminated
- not on file
- Reason
- Lack of 510K clearance
- Root cause
- No Marketing Application
- 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.
- Quantity
- 11202 units
- 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.
- Lot, serial or model codes
- All Lots UDI:
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPL
- Firm FEI
- 1000511598
- Firm city
- Pendergrass
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28