Mederi Therapeutics, Inc: Medical Device Recall in 2017 - (Recall #: Z-2050-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 3, 2017

Date Posted: May 17, 2017

Recall Number: Z-2050-2017

Event ID: 76972

Reason for Recall:

Product sterility compromised due to breach in sterile barrier package

Status: Terminated

Product Quantity: 1458 units

Code Information:

Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated