The Recall Desk

FDA (Devices) recall action 98208

SunMed Holdings, LLC recalled 4 products on 2026-02-04

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2026-02-04
Critical
3
Units
116,356

Why these products were recalled

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • CriticalFDA (Devices)··2026-02-04

    Pediatric emergency tapes recalled over potentially harmful drug dosing errors

    SunMed Holdings is recalling 95,300 units of the Broselow Pediatric Emergency Rainbow Tape because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-02-04

    MR 7700 systems recalled over elastography stiffness value errors

    Philips North America is recalling 9 units of the MR 7700 MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2026-02-04

    Filled Broselow organizers recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 89 units of the Filled Broselow Organizer, model 7730IALS, because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Comp
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2026-02-04

    Broselow Rainbow Tape 7700RE recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 20,583 units of the Broselow Pediatric Emergency Rainbow Tape, model 7700RE, because it contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Distribution
    0 states