The Recall Desk

Manufacturer

Mederi Therapeutics, Inc

1 recall in our database name Mederi Therapeutics, Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2017-05-17

Of the 1 recalls from Mederi Therapeutics, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • SevereFDA (Devices)·Z-2050-2017·2017-05-17

    Mederi Stretta Catheter Recalled Due to Sterility Compromise

    Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide