The Recall Desk

Manufacturer

ROi CPS LLC

78 recalls in our database name ROi CPS LLC as the manufacturing or recalling firm.

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.

76–78 of 78

  • HighFDA (Devices)·Z-2169-2021·2021-08-11

    Regard Newborn Heel Warmer Kit Recalled for Inadequate Safety Instructions

    ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.

    Product
    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2167-2021·2021-08-11

    Newborn Heel Warmer Kit Instructions Updated for Activation Safety

    The Regard Newborn Kit heel warmer is being recalled. Updated instructions now require that the device be activated away from the user's face and away from the infant and others.

    Product
    Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2168-2021·2021-08-11

    Infant Heel Warmer Instructions Updated for Activation Safety Warning

    ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.

    Product
    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
    Category
    Medical Device
    Distribution
    0 states