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.

1–25 of 78

  • HighFDA (Devices)·Z-1047-2025·2025-02-12

    Newborn Resuscitator Kit Recalled for Inline Spring Defect

    414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.

    Product
    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3159-2024·2024-09-25

    Convenience kits recalled for containing defective medical syringes

    ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.

    Product
    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2685-2024·2024-08-28

    Regard Kit Decanters Recalled for Defective Sterile Packaging

    ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.

    Product
    Regard Kit containing the Microtek decanter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0620-2024·2024-01-24

    Surgical Convenience Kit Recalled Due to Defective Component

    ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.

    Product
    regard Operative LAP, Item Number 800943001; surgical convenience kit
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0596-2024·2024-01-10

    Regard Dressing Change Kit Recalled Due to Defective Irrigation Solution

    ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.

    Product
    Regard Dressing change kit, Item Number 800026006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2024·2023-11-22

    Cardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions

    ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.

    Product
    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0070-2024·2023-10-11

    Medical Convenience Kit Recalled for Defective Dermatome Blades

    ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.

    Product
    GS0008 2Y - Burn Pack - STL, Item Number 880082025
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1431-2023·2023-05-03

    Surgical Convenience Kits Recalled for Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2023·2023-05-03

    Surgical Convenience Kits Recalled Due to Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2023·2023-05-03

    Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2023·2023-05-03

    Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

    ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2023·2023-05-03

    Sterile surgical cardiac catheterization kit recalled for light handle cover separation

    A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2023·2023-05-03

    Sterile surgical C-section kit light handle covers recalled for separation risk

    ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2023·2023-05-03

    Sterile surgical kit recalled due to light handle cover separation risk

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2023·2023-05-03

    Sterile Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

    Product
    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2023·2022-11-30

    Regard SPINE Surgical Kits Recalled for Containing Unsafe Drapes

    ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0288-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.

    Product
    regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0300-2023·2022-11-30

    Regard Retinal Pack surgical kits recalled for defective 3M drapes

    ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.

    Product
    regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0292-2023·2022-11-30

    Neurosurgery Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.

    Product
    regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0298-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled Surgical Drapes

    Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0302-2023·2022-11-30

    Surgical Convenience Kits with Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0322-2023·2022-11-30

    Shoulder arthroscopy surgical convenience kits recalled due to defective 3M drapes

    ROi CPS LLC is recalling 90 regard shoulder arthroscopy surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0290-2023·2022-11-30

    Eye Surgery Convenience Kits Recalled for Containing Recalled 3M Drapes

    ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.

    Product
    regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0291-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled 3M drapes

    Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0311-2023·2022-11-30

    Neuro surgery kits recalled for defective 3M surgical drapes

    ROi CPS LLC is recalling 790 neuro surgery convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states