FDA Medical devices recall ·
PIE Trolley System Model: 2005 recall
- Recall number
- Z-1461-2026
- Date
- (initiated January 14, 2026)
- Company / brand
- Edermy LLC
115 Enterprise Dr Ste A, Pendergrass, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PIE Trolley System Model: 2005
Why was it recalled?
Lack of 510K clearance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots
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.
States: Alabama Arizona California Colorado Florida Illinois Indiana Massachusetts Minnesota Missouri North Carolina New York Ohio Pennsylvania South Carolina Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1461-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.