The Recall Desk

Manufacturer

Zien Medical Technologies, Inc

1 recall in our database name Zien Medical Technologies, Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-09-30

Of the 1 recalls from Zien Medical Technologies, 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

  • ModerateFDA (Devices)·Z-2800-2015·2015-09-30

    Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk

    Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.

    Product
    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
    Category
    Medical Device
    Distribution
    Distributed nationwide