FDAJuly 15, 2026
Reign Medical Clench Staple System Recall Over Unestablished Performance Characteristics
FDA published this notice on July 15, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- July 15, 2026
- Recall class
- Class II
- Reason given by the agency
- Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- Distribution
- US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.
- Official source
- the notice at its source
Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers
Source: FDA.