The Recall Desk

Manufacturer

ROi CPS LLC

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

What the numbers show

Total
86
Critical
1
Severe
1
Most recent
2025-02-12

Of the 86 recalls from ROi CPS LLC we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) 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.

76–86 of 86

  • 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
    1 state
  • 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
    1 state
  • 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
    1 state
  • HighFDA (Devices)·Z-1376-2021·2021-04-14

    ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits

    ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.

    Product
    Regard, Item Number 830067009, custom cardiovascular procedure kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2021·2021-01-06

    ROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges

    ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.

    Product
    Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0524-2021·2020-12-09

    ROi CPS Recalls Labor and Delivery Kits Due to Labeling Error

    ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.

    Product
    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2020·2020-07-08

    ROi CPS Recalls Isolation Droplet Bundle Kits Due to Labeling Error

    ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits because the kits are labeled with an expiration date later than the expiration date of the soonest component.

    Product
    Isolation Droplet Bundle Kit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2466-2020·2020-07-08

    ROi CPS LLC Recalls Respirator Crash Cart Kits Due to Labeling Error

    ROi CPS LLC is recalling 200 Respirator Crash Cart Kits because the kits are labeled with an expiration date later than the soonest component to expire.

    Product
    Respirator Crash Cart Kit
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2265-2020·2020-06-17

    ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes

    ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.

    Product
    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2020·2020-02-05

    ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices

    ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.

    Product
    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - M
    Category
    Medical Device
    Distribution
    4 states