Mederi Stretta Catheter and Accessory Kit — Class II medical device recall Z-2050-2017
Terminated recall by Mederi Therapeutics, Inc, reported 2017-05-17, distributed nationwide. Product sterility compromised due to breach in sterile barrier package
| Recall number | Z-2050-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mederi Therapeutics, Inc, Norwalk, CT, United States |
| Recall initiated | 2017-04-03 |
| Classified | 2017-05-08 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CN, CR, EG, GB, IN, IT, JO, KW, MY, PL, TR |
| Quantity | 1,458 units |
| Reason classes | sterility |
| Lot numbers | 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 |
| Model numbers | 175-5580 |
Product
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
Reason for recall
Product sterility compromised due to breach in sterile barrier package
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2050-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.