The Recall Desk

Manufacturer

Sotera Wireless, Inc.

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2013-08-07

Of the 2 recalls from Sotera Wireless, 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

  • HighFDA (Devices)·Z-1818-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk

    Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.

    Product
    ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1817-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk

    Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.

    Product
    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 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.

Sotera Wireless (United States)

company in San Diego, United States

Country
United States
Founded
2002

Official website

Source: Wikidata (Q30260707), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.