The Recall Desk

Manufacturer

C2 Therapeutics, Inc.

1 recall in our database name C2 Therapeutics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2017-03-22

Of the 1 recalls from C2 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 0 (0%) 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

  • HighFDA (Devices)·Z-1477-2017·2017-03-22

    C2 CryoBalloon Controller Cap Recall Due to Cracking Risk

    C2 Therapeutics is recalling 755 C2 CryoBalloon Controller Caps because they may crack when tightened, potentially compromising the device's integrity.

    Product
    C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012
    Category
    Medical Device
    Distribution
    Distributed nationwide