ROi CPS LLC

FDA recalling firm · 28 enforcement events · 86 product records · 2020–2024 · MO

ROi CPS LLC has 28 FDA enforcement events on this register (86 product records) between 2020 and 2024: 28 device; the busiest year was 2022 with 9.

11% of its events are Class I; the most common class is Class II (24). 7 events are listed as ongoing; the recalling firm's address is in MO.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
26 Dec 2024	regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.	Device	Class I	1	Ongoing
24 Jul 2024	regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009	Device	Class II	1	Ongoing
17 Jun 2024	Regard Kit containing the Microtek decanter	Device	Class II	1	Ongoing
18 Dec 2023	regard Operative LAP, Item Number 800943001; surgical convenience kit	Device	Class I	1	Terminated
20 Nov 2023	Regard Dressing change kit, Item Number 800026006	Device	Class I	1	Terminated
21 Sep 2023	Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit	Device	Class II	1	Ongoing
11 Sep 2023	GS0008 2Y - Burn Pack - STL, Item Number 880082025	Device	Class II	1	Ongoing
22 Mar 2023	Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.	Device	Class II	8	Ongoing
20 Oct 2022	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	Device	Class II	40	Terminated
3 Jun 2022	Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.	Device	Class II	2	Terminated
20 May 2022	regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.	Device	Class II	1	Terminated
3 May 2022	Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm	Device	Class II	1	Terminated
3 May 2022	regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003	Device	Class II	1	Terminated
21 Mar 2022	Regard brand CABG Pack A and B - Spartanburg	Device	Class II	1	Terminated
18 Mar 2022	Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.	Device	Class II	3	Terminated
24 Feb 2022	Regard Custom Procedure Kits containing BD Luer Lok Access Devices	Device	Class III	1	Terminated
13 Jan 2022	Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile	Device	Class II	1	Terminated
30 Nov 2021	Regard, T AND A - Rogers, sterilized convenience kits	Device	Class II	1	Terminated
4 Nov 2021	regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.	Device	Class II	1	Terminated
10 Aug 2021	REGARD Basic Cataract tray	Device	Class II	7	Terminated
14 Jun 2021	Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.	Device	Class II	3	Terminated
26 Mar 2021	Regard Dressing Change Tray	Device	Class II	1	Terminated
4 Mar 2021	Regard, Item Number 830067009, custom cardiovascular procedure kit	Device	Class II	1	Ongoing
9 Nov 2020	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) Regard, LAP CHOLE, Item 800003011, Lot #…	Device	Class II	1	Terminated
12 Oct 2020	Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.	Device	Class II	1	Terminated
19 May 2020	Isolation Droplet Bundle Kit	Device	Class II	2	Terminated
20 Apr 2020	Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.	Device	Class II	1	Terminated
3 Jan 2020	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 - Max Barrier Central Line Dual Lumen 16cm,…	Device	Class II	1	Terminated

By type and class

Device28

Class II24

Class I3

Class III1

Class I: 11% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for ROi CPS LLC by year initiated.

Questions and answers

How many FDA recalls has ROi CPS LLC had?

28 enforcement events (86 product records) on this register, 2020–2024: 28 device.

Are any ROi CPS LLC recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are ROi CPS LLC recalls?

24 Class II, 3 Class I, 1 Class III. 11% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.