FDA Medical devices recall ·
Paragonix Technologies Inc recall
- Recall number
- Z-2967-2026
- Date
- (initiated July 20, 2026)
- Company / brand
- Paragonix Technologies Inc.
639 Granite St Ste 408, Braintree, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1445 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Why was it recalled?
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
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 Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
Distribution
US Nationwide distribution in the states and territories of AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.
States: Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Wisconsin West 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-2967-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.