FDA (Devices) recall action 92301
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
There is a potential that valve assemblies will not open. preventing fluid from draining.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.
Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.
Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.
Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.
Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.
Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.
Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.
Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.