ROi CPS Recalls
86 recalls on record · February 5, 2020 to February 12, 2025 · Medical Devices
Recalls by year
20
21
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 12, 2025Medical DevicesFDA
ROi CPS LLC recalls regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to
Hazard: 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..
September 25, 2024Medical DevicesFDA
ROi CPS LLC recalls regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Hazard: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
August 28, 2024Medical DevicesFDA
ROi CPS LLC recalls Regard Kit containing the Microtek decanter
Hazard: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
January 24, 2024Medical DevicesFDA
ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit
Hazard: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
January 10, 2024Medical DevicesFDA
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
Hazard: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
November 22, 2023Medical DevicesFDA
ROi CPS LLC recalls Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Hazard: 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.
October 11, 2023Medical DevicesFDA
ROi CPS LLC recalls GS0008 2Y - Burn Pack - STL, Item Number 880082025
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regar
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number
Hazard: 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.
May 3, 2023Medical DevicesFDA
ROi CPS LLC recalls Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item
Hazard: 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.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
November 30, 2022Medical DevicesFDA
ROi CPS LLC recalls ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
Hazard: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.