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ROI CPS, LLC

Last updated May 23, 2026

What ROI CPS, LLC makes

ROI CPS, LLC manufactures single-use surgical kits for general, laparoscopic, cardiothoracic, and ENT procedures, as well as central venous catheterization and bladder irrigation kits. Their portfolio also includes fluid/device delivery catheters for cardiac procedures and non-medicated suture kits. All products are designed for short-term or one-time clinical use without medication.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for medical device compliance.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does ROI CPS, LLC manufacture?

ROI CPS, LLC specializes in single-use surgical kits for various procedures, including general surgery, laparoscopic surgery, cardiothoracic surgery, and ENT (ear, nose, and throat) surgery. Their product line also includes central venous catheterization kits for short-term use, bladder irrigation kits, and fluid/device delivery catheters for cardiac procedures. Additionally, they produce non-medicated suture kits designed for one-time clinical use.

Where is ROI CPS, LLC based, and what regulatory requirements do they follow?

ROI CPS, LLC is based in the United States. As a manufacturer, they develop devices in compliance with applicable U.S. regulatory standards, including those set by the FDA. Their products are designed to meet the requirements for single-use medical devices, ensuring they align with regulatory expectations for safety and performance.

Which regulatory registries or databases list ROI CPS, LLC’s devices?

ROI CPS, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for their products, allowing healthcare providers and regulators to identify and verify the devices based on their assigned UDI.

How are ROI CPS, LLC’s devices classified under FDA regulations?

ROI CPS, LLC’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and clinical context, as outlined in FDA guidelines.

Why are ROI CPS, LLC’s surgical kits designed for single-use only?

ROI CPS, LLC’s surgical kits are designed for single-use to minimize infection risks and ensure sterility in clinical settings. Single-use devices are manufactured under strict controls to maintain hygiene and reliability, reducing the need for reprocessing, which can introduce contamination or compromise performance. This aligns with best practices in surgical safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117174678

Catalogue (2134)

Page 4 of 43

Device	Model / Reference	Registries	Class	Status
Regard™	GS00082V	FDA UDI	Class I	Unknown
Regard™	HT01060B	FDA UDI	Class II	Unknown
Regard™	GS00085AC	FDA UDI	Class II	Unknown
Regard™	OB00101R	FDA UDI	Class II	Unknown
Regard™	GS00405J	FDA UDI	Class II	Unknown
Regard™	GS00311B	FDA UDI	Class II	Unknown
Regard™	LD00692E	FDA UDI	Class II	Unknown
Regard™	OR00180Q	FDA UDI	Class I	Unknown
Regard™	AN01185	FDA UDI	Class II	Unknown
Regard™	LD00312E	FDA UDI	Class II	Unknown
Regard™	NU00974H	FDA UDI	Class I	Unknown
Regard™	LD00377L	FDA UDI	Class II	Unknown
Regard™	OR00827F	FDA UDI	Class I	Unknown
Regard™	HT00997E	FDA UDI	Class II	Unknown
Regard™	AN00211M	FDA UDI	Class II	Unknown
Regard™	LD00427P	FDA UDI	Class II	Unknown
Regard™	NU00219R	FDA UDI	Class I	Unknown
Regard™	CV00261J	FDA UDI	Class II	Unknown
Regard™	CV00079K	FDA UDI	Class II	Unknown
Regard™	GS00158K	FDA UDI	Class II	Unknown
Regard™	GS01075	FDA UDI	Class II	Unknown
Regard™	GS00396H	FDA UDI	Class II	Unknown
Regard™	GY01058B	FDA UDI	Class II	Unknown
Regard™	EY00812F	FDA UDI	Class II	Unknown
Regard™	GS00085AA	FDA UDI	Class II	Unknown
Regard™	OR00124W	FDA UDI	Class I	Unknown
Regard™	HT01015A	FDA UDI	Class II	Unknown
Regard™	NU00140AD	FDA UDI	Class I	Unknown
Regard™	ET01149	FDA UDI	Class II	Unknown
Regard™	OR01100A	FDA UDI	Class I	Unknown
Regard™	NU01001E	FDA UDI	Class I	Unknown
Regard™	GS00221H	FDA UDI	Class II	Unknown
Regard™	AN01246B	FDA UDI	Class II	Unknown
Regard™	NU01086B	FDA UDI	Class I	Unknown
Regard™	OR00351M	FDA UDI	Class I	Unknown
Regard™	OB00043U	FDA UDI	Class II	Unknown
Regard™	HT00605F	FDA UDI	Class II	Unknown
Regard™	LD00108R	FDA UDI	Class II	Unknown
Regard™	OB00234H	FDA UDI	Class II	Unknown
Regard™	CV01059B	FDA UDI	Class II	Unknown
Regard™	OR00058H	FDA UDI	Class I	Unknown
Regard™	LD00027T	FDA UDI	Class II	Unknown
Regard™	HT00253G	FDA UDI	Class II	Unknown
Regard™	GS00091Z	FDA UDI	Class II	Unknown
Regard™	NU00974G	FDA UDI	Class I	Unknown
Regard™	OR00231J	FDA UDI	Class II	Unknown
Regard™	NU01047B	FDA UDI	Class I	Unknown
Regard™	OR00800L	FDA UDI	Class I	Unknown
Regard™	GS01007C	FDA UDI	Class II	Unknown
Regard™	AN00007O	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (86)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

ROI CPS, LLC has initiated 86 recall records between January 3, 2020, and December 26, 2024, with statuses recorded as open, classified, or terminated. The reasons cited include component recalls (e.g., Medline Endoscopy Bedside Cleaning products, Povidone-Iodine swabs, drug kit components), labeling errors (incorrect expiration dates, mislabeled kits, missing latex warnings), sterile barrier breaches (slits in drapes, damaged decanter packaging), and potential performance issues (e.g., Inline Controller spring defects affecting ventilation equipment). Some recalls stemmed from vendor-issued alerts, while others involved direct manufacturer actions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 26, 2024	Z-1047-2025	—	open, classified	There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Jul 24, 2024	Z-3159-2024	—	open, classified	Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Jun 17, 2024	Z-2685-2024	—	open, classified	Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Dec 18, 2023	Z-0620-2024	—	terminated	Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Nov 20, 2023	Z-0596-2024	—	terminated	ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Sep 21, 2023	Z-0315-2024	—	open, classified	Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Sep 11, 2023	Z-0070-2024	—	open, classified	Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Mar 22, 2023	Z-1438-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1431-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1436-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1435-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1433-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1434-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1432-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mar 22, 2023	Z-1437-2023	—	open, classified	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Oct 20, 2022	Z-0306-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0310-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0293-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0286-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0285-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0317-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0315-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0304-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0297-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0302-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0294-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0289-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0288-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0321-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0284-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0307-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0308-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0295-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0309-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0300-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0283-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0311-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0287-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0296-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0319-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0314-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0299-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0316-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0320-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0290-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0292-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0318-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0301-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0291-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0322-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0312-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0303-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0298-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0305-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Oct 20, 2022	Z-0313-2023	—	terminated	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Jun 3, 2022	Z-1407-2022	—	terminated	Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Jun 3, 2022	Z-1408-2022	—	terminated	Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
May 20, 2022	Z-1295-2022	—	terminated	A nonsterile component was packaged in a sterile convenience kit.
May 3, 2022	Z-1255-2022	—	terminated	Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
May 3, 2022	Z-1250-2022	—	terminated	Potential for the tip of the electrode to detach during use.
Mar 21, 2022	Z-1051-2022	—	terminated	Kits were packed into shipping boxes incorrectly.
Mar 18, 2022	Z-1005-2022	—	terminated	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Mar 18, 2022	Z-1006-2022	—	terminated	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Mar 18, 2022	Z-1004-2022	—	terminated	A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Feb 24, 2022	Z-0837-2022	—	terminated	Recalled devices were packaged in convenience kits.
Jan 13, 2022	Z-0693-2022	—	terminated	Products are mislabeled with the incorrect product identification on individual kit labeling.
Nov 30, 2021	Z-0469-2022	—	terminated	Kits lacks rubber latex warning label.
Nov 4, 2021	Z-0411-2022	—	terminated	The kit contains a non-sterile needle.
Aug 10, 2021	Z-0255-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0250-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0251-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0252-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0254-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0253-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Aug 10, 2021	Z-0256-2022	—	terminated	Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Jun 14, 2021	Z-2168-2021	—	terminated	Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Jun 14, 2021	Z-2167-2021	—	terminated	Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Jun 14, 2021	Z-2169-2021	—	terminated	Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Mar 26, 2021	Z-1542-2021	—	terminated	ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Mar 4, 2021	Z-1376-2021	—	open, classified	ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Nov 9, 2020	Z-0737-2021	—	terminated	Gauze sponges contained in custom kits may be flaking or fraying.
Oct 12, 2020	Z-0524-2021	—	terminated	Labeling error, incorrect expiration date.
May 19, 2020	Z-2465-2020	—	terminated	Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
May 19, 2020	Z-2466-2020	—	terminated	Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Apr 20, 2020	Z-2265-2020	—	terminated	Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Jan 3, 2020	Z-0918-2020	—	terminated	ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.