Republic, MO, United States
ROi CPS LLC recalls
28 recalls recorded since 2018, most recently on 26 December 2024. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls28
Ongoing (FDA)7
Terminated or completed21
Class I (FDA)3
Ongoing Class I Medical devices
- Recall started
- 26 December 2024
- Reason
- 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..
- Distribution
- Distribution was made to MO. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1047-2025
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Ongoing Class II Medical devices
- Recall started
- 24 July 2024
- Reason
- Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3159-2024
- regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Ongoing Class II Medical devices
- Recall started
- 17 June 2024
- Reason
- Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- Distribution
- US Nationwide distribution in the state of MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2685-2024
- Regard Kit containing the Microtek decanter
Terminated Class I Medical devices
- Recall started
- 18 December 2023
- Terminated
- 3 October 2024
- Reason
- Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- Distribution
- US distribution to Louisiana
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0620-2024
- regard Operative LAP, Item Number 800943001; surgical convenience kit
Terminated Class I Medical devices
- Recall started
- 20 November 2023
- Terminated
- 5 August 2024
- Reason
- ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
- Distribution
- US Nationwide distribution in the state of Louisiana.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0596-2024
- Regard Dressing change kit, Item Number 800026006
Ongoing Class II Medical devices
- Recall started
- 21 September 2023
- Reason
- 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.
- Distribution
- MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0315-2024
- Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Ongoing Class II Medical devices
- Recall started
- 11 September 2023
- Reason
- 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.
- Distribution
- Missouri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0070-2024
- GS0008 2Y - Burn Pack - STL, Item Number 880082025
Ongoing Class II Medical devices
- Recall started
- 22 March 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1436-2023, Z-1435-2023, Z-1434-2023, Z-1432-2023, Z-1438-2023, Z-1437-2023, Z-1431-2023, Z-1433-2023
- Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
- Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
- Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
- 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 R
- 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
- 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, NU0100
- Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
- Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Terminated Class II Medical devices
- Recall started
- 20 October 2022
- Terminated
- 1 April 2026
- Reason
- Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- Distribution
- LA, MO, NC, FL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0310-2023, Z-0287-2023, Z-0300-2023, Z-0291-2023, Z-0288-2023, Z-0289-2023, Z-0320-2023, Z-0303-2023, Z-0292-2023, Z-0309-2023, Z-0294-2023, Z-0304-2023 and 28 more
- regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
- regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
- regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
- regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
- regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
- regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
- regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
- ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
- and 32 more product lines
Terminated Class II Medical devices
- Recall started
- 3 June 2022
- Terminated
- 14 April 2023
- Reason
- Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
- Distribution
- Distribution was made to MO. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1407-2022, Z-1408-2022
- Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
- Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Terminated Class II Medical devices
- Recall started
- 20 May 2022
- Terminated
- 2 May 2023
- Reason
- A nonsterile component was packaged in a sterile convenience kit.
- Distribution
- US Nationwide distribution in the state of FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1295-2022
- regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Terminated Class II Medical devices
- Recall started
- 3 May 2022
- Terminated
- 31 May 2024
- Reason
- Potential for the tip of the electrode to detach during use.
- Distribution
- Distributed to North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1250-2022
- Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Terminated Class II Medical devices
- Recall started
- 3 May 2022
- Terminated
- 27 June 2022
- Reason
- Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1255-2022
- regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Terminated Class II Medical devices
- Recall started
- 21 March 2022
- Terminated
- 28 December 2023
- Reason
- Kits were packed into shipping boxes incorrectly.
- Distribution
- Recall impacted one domestic consignee in NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1051-2022
- Regard brand CABG Pack A and B - Spartanburg
Terminated Class II Medical devices
- Recall started
- 18 March 2022
- Terminated
- 2 August 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of Missouri.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1005-2022, Z-1006-2022, Z-1004-2022
- Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, L
- Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
- 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, LD00
Terminated Class III Medical devices
- Recall started
- 24 February 2022
- Terminated
- 25 April 2022
- Reason
- Recalled devices were packaged in convenience kits.
- Distribution
- US Nationwide distribution in the state of Missouri.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0837-2022
- Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Terminated Class II Medical devices
- Recall started
- 13 January 2022
- Terminated
- 28 September 2022
- Reason
- Products are mislabeled with the incorrect product identification on individual kit labeling.
- Distribution
- Missouri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2022
- Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Terminated Class II Medical devices
- Recall started
- 30 November 2021
- Terminated
- 7 August 2023
- Reason
- Kits lacks rubber latex warning label.
- Distribution
- US Nationwide distribution in the state of MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0469-2022
- Regard, T AND A - Rogers, sterilized convenience kits
Terminated Class II Medical devices
- Recall started
- 4 November 2021
- Terminated
- 7 August 2023
- Reason
- The kit contains a non-sterile needle.
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0411-2022
- regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Terminated Class II Medical devices
- Recall started
- 10 August 2021
- Terminated
- 16 June 2023
- Reason
- 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.
- Distribution
- US Nationwide in the states of FL, LA and MO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0256-2022, Z-0252-2022, Z-0250-2022, Z-0253-2022, Z-0251-2022, Z-0255-2022, Z-0254-2022
- REGARD Vitrectomy Tray
- REGARD Ear Tray
- REGARD Basic Cataract tray
- REGARD Newborn Tray
- REGARD Core Biopsy Tray
- REGARD Ultrasound Tray
- REGARD Stereotactic Tray
Terminated Class II Medical devices
- Recall started
- 14 June 2021
- Terminated
- 8 March 2023
- Reason
- 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."
- Distribution
- Missouri
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2168-2021, Z-2169-2021, Z-2167-2021
- Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
- Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
- Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Terminated Class II Medical devices
- Recall started
- 26 March 2021
- Terminated
- 30 January 2023
- Reason
- ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
- Distribution
- US Nationwide distribution in the state of Louisiana.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1542-2021
- Regard Dressing Change Tray
Ongoing Class II Medical devices
- Recall started
- 4 March 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of Missouri.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1376-2021
- Regard, Item Number 830067009, custom cardiovascular procedure kit
Terminated Class II Medical devices
- Recall started
- 9 November 2020
- Terminated
- 13 May 2021
- Reason
- Gauze sponges contained in custom kits may be flaking or fraying.
- Distribution
- US Domestic Distribution Only: MO, NC, LA and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0737-2021
- 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 #
Terminated Class II Medical devices
- Recall started
- 12 October 2020
- Terminated
- 13 May 2021
- Reason
- Labeling error, incorrect expiration date.
- Distribution
- US Nationwide distribution in the states of MO and OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0524-2021
- Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Terminated Class II Medical devices
- Recall started
- 19 May 2020
- Terminated
- 1 September 2020
- Reason
- 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.
- Distribution
- Domestic distribution only to: MO and LA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2466-2020, Z-2465-2020
- Respirator Crash Cart Kit
- Isolation Droplet Bundle Kit
Terminated Class II Medical devices
- Recall started
- 20 April 2020
- Terminated
- 21 August 2020
- Reason
- Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
- Distribution
- US nationwide distribution in the states of MO, AR and OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2265-2020
- Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 20 November 2020
- Reason
- ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
- Distribution
- US: AR, OK, MO, KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0918-2020
- 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-
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.