The Recall Desk

Manufacturer

Elana, Inc.

2 recalls in our database name Elana, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-12-14

Of the 2 recalls from Elana, 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.

1–2 of 2

  • ModerateFDA (Devices)·Z-0698-2017·2016-12-14

    Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity

    Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.

    Product
    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1143-2013·2013-04-24

    Elana Catheter Sizer 2.0 Recalled for Unapproved Distribution

    Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.

    Product
    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
    Category
    Medical Device
    Distribution
    3 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Elana

Polish company

Country
Poland
Founded
1961

Official website

Source: Wikidata (Q28676570), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.