Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580

Recall Insight

This FDA Devices action (record #Z-2050-2017) was formally reported on May 17, 2017, with the manufacturer initiating the action on April 3, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Mederi Therapeutics, Inc is listed as the recalling firm, operating out of Norwalk, CT. Federal records indicate 1458 units units are affected.

The documented reason for this recall is: Product sterility compromised due to breach in sterile barrier package Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.