--- title: "ROi CPS LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ROi CPS LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/roi-cps-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ROi CPS LLC recall records **13** reported ongoing 68 records in this archive. Latest source date Dec 26, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 26, 2024 FDA device enforcement ### [regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.](https://isitonrecall.com/recall/fda-device-z-1047-2025-regard-item-number-830106006-ld01114f-newborn-kit-containing-the-component-neo-tee-resuscitator-conv/) 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 impa... Class I Reported ongoing Distribution: Distribution was made to MO. There was no government/military/foreign distribution. [Official source for regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitat...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1047-2025%22) Jul 24, 2024 FDA device enforcement ### [regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009](https://isitonrecall.com/recall/fda-device-z-3159-2024-regard-clinical-packaging-solutions-ht00376i-special-procedure-item-number-800223009/) Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. Class II Reported ongoing Distribution: US Nationwide distribution in the state of North Carolina. [Official source for regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3159-2024%22) Jun 17, 2024 FDA device enforcement ### [Regard Kit containing the Microtek decanter](https://isitonrecall.com/recall/fda-device-z-2685-2024-regard-kit-containing-the-microtek-decanter/) Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. Class II Reported ongoing Distribution: US Nationwide distribution in the state of MO. [Official source for Regard Kit containing the Microtek decanter](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2685-2024%22) Dec 18, 2023 FDA device enforcement ### [regard Operative LAP, Item Number 800943001; surgical convenience kit](https://isitonrecall.com/recall/fda-device-z-0620-2024-regard-operative-lap-item-number-800943001-surgical-convenience-kit/) Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. Class I Reported terminated Distribution: US distribution to Louisiana [Official source for regard Operative LAP, Item Number 800943001; surgical convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0620-2024%22) Nov 20, 2023 FDA device enforcement ### [Regard Dressing change kit, Item Number 800026006](https://isitonrecall.com/recall/fda-device-z-0596-2024-regard-dressing-change-kit-item-number-800026006/) ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. Class I Reported terminated Distribution: US Nationwide distribution in the state of Louisiana. [Official source for Regard Dressing change kit, Item Number 800026006](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0596-2024%22) Sep 21, 2023 FDA device enforcement ### [Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit](https://isitonrecall.com/recall/fda-device-z-0315-2024-regard-cv-pk-item-numbers-a-880289014-b-880289015-cardiovascular-convenience-kit/) 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 ... Class II Reported ongoing Distribution: MO [Official source for Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0315-2024%22) Sep 11, 2023 FDA device enforcement ### [GS0008 2Y - Burn Pack - STL, Item Number 880082025](https://isitonrecall.com/recall/fda-device-z-0070-2024-gs0008-2y-burn-pack-stl-item-number-880082025/) 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. Class II Reported ongoing Distribution: Missouri [Official source for GS0008 2Y - Burn Pack - STL, Item Number 880082025](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0070-2024%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.](https://isitonrecall.com/recall/fda-device-z-1431-2023-sterile-surgical-convenience-kits-1-regard-item-number-880405003-gs01011c-general-laparoscopy-2-rega/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparosco...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1431-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Num...](https://isitonrecall.com/recall/fda-device-z-1432-2023-sterile-surgical-convenience-kits-1-regard-item-number-880353009-gs00797i-laparotomy-pk-2-regard-ite/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1432-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.](https://isitonrecall.com/recall/fda-device-z-1433-2023-sterile-surgical-convenience-kit-regard-item-number-800718003-gy00923c-wph-major-vaginal-pack/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1433-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.](https://isitonrecall.com/recall/fda-device-z-1434-2023-sterile-surgical-convenience-kit-regard-item-number-880393003-ht00997c-cardiac-cath/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1434-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.](https://isitonrecall.com/recall/fda-device-z-1435-2023-sterile-surgical-convenience-kit-regard-item-number-800753005-gy00958e-wph-gyn-laparoscopy-pack/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1435-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.](https://isitonrecall.com/recall/fda-device-z-1436-2023-sterile-surgical-convenience-kit-regard-item-number-800706005-ld0091e-oh-c-section-pack/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1436-2023%22) Mar 22, 2023 FDA device enforcement ### [Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. rega...](https://isitonrecall.com/recall/fda-device-z-1437-2023-sterile-surgical-convenience-kits-1-regard-item-number-800756005-nu00961e-oh-laminectomy-cust-pack-2/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1437-2023%22) Mar 22, 2023 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1438-2023-sterile-surgical-convenience-kits-1-regard-item-number-880473001-or01105a-total-shoulder-hip-2-regar/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. [Official source for Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1438-2023%22) Oct 20, 2022 FDA device enforcement ### [regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit](https://isitonrecall.com/recall/fda-device-z-0283-2023-regard-laminectomy-nu01140-item-number-900940-neuro-surgery-convenience-kit/) Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class II Reported terminated Distribution: LA, MO, NC, FL [Official source for regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0283-2023%22) Oct 20, 2022 FDA device enforcement ### [regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit](https://isitonrecall.com/recall/fda-device-z-0284-2023-regard-foot-pack-or00123y-item-number-880118-orthopedic-surgery-convenience-kit/) Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class II Reported terminated Distribution: LA, MO, NC, FL [Official source for regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0284-2023%22) Oct 20, 2022 FDA device enforcement ### [regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit](https://isitonrecall.com/recall/fda-device-z-0285-2023-regard-total-joint-or00446f-item-number-880291-orthopedic-surgery-convenience-kit/) Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class II Reported terminated Distribution: LA, MO, NC, FL [Official source for regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0285-2023%22) Oct 20, 2022 FDA device enforcement ### [regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit](https://isitonrecall.com/recall/fda-device-z-0286-2023-regard-kyphoplasty-or01101-item-number-880469-orthopedic-surgery-convenience-kit/) Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class II Reported terminated Distribution: LA, MO, NC, FL [Official source for regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0286-2023%22) Oct 20, 2022 FDA device enforcement ### [regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit](https://isitonrecall.com/recall/fda-device-z-0287-2023-regard-basic-neuro-nu00259r-item-number-800021018-neuro-surgery-convenience-kit/) Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class II Reported terminated Distribution: LA, MO, NC, FL [Official source for regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0287-2023%22) ## Reasons in these listed records - 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 vent... - Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. - Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. - Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. These examples come from this result page and are not a ranking of every recall reason. ## Checking ROi CPS LLC ### Is there a recall on roi cps llc right now? This archive contains 68 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search ROi CPS LLC](https://isitonrecall.com/check/?q=ROi%20CPS%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)