Roi Cps recalls
Roi Cps appears in 86 official U.S. recall notices indexed by RecallRadar, most recently on 2025-02-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 86 |
|---|---|
| Published | 2020-02-05 to 2025-02-12 |
| By agency | FDA Device (86) |
| By classification | Class II (82), Class I (3), Class III (1) |
| By status | terminated (72), ongoing (14) |
| Distribution named in notices | AR, FL, KS, LA, MO, NC, OK, US |
Recalls
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps
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… - regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Device · Class II · 2024-09-25 · Roi Cps
Reason: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps
Reason: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps
Reason: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps
Reason: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. - Regard CV PK, Item Numbers a) 880289014, b) 880289015
FDA Device · Class II · 2023-11-22 · Roi Cps
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… - GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA Device · Class II · 2023-10-11 · Roi Cps
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. - Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy
FDA Device · Class II · 2023-05-03 · Roi Cps
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. - ¿regard SHOULDER PK, GS00125U, Item Number 880120021
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard TOTAL JOINT, OR00446F, Item Number 880291
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - ¿regard EYE TRAY, EY00099AE, Item Number 880099031
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SPINE PACK,NU00395J, Item Number 800241010
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard ACDF, NU00698H, Item Number 800246008
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard MAJOR CRANI, NU00921E, Item Number 800716005
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard ACDF, NU00698I, Item Number 800246009
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard CERVICAL PACK, NU00303H, Item Number 800058008
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard NEURO TRAY, NU00160R, Item Number 880158018
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard VITRECTOMY PK, EY00938C, Item Number 800733003
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard FOOT PACK, OR00123Y, Item Number 880118
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard MAJOR EAR, ET00326J, Item Number 800070010
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard MINOR NEURO, NU00140AD, Item Number 880135030
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SHOULDER PACK, GS00125V, Item Number 880120022
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SPINE PACK , NU00193N, Item Number 880179014
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard VITRECTOMY PACK, EY00266H, Item Number 800028008
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard CATARACT, EY00450L, Item Number 880295012
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard CATARACT, EY00450K, Item Number 880295011
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard DAVINCI PACK, GS00137W, Item Number 880132023
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SPINE , NU00974F, Item Number 800769006
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard RETINAL PACK, EY00935C, Item Number 800730003
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard SPINE, OR01100A, Item Number 880468001
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard HAND PACK, OR00594K, Item Number 800243011
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard KYPHOPLASTY, OR01101, Item Number 880469
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard LAMINECTOMY, NU01140, Item Number 900940
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard LATERAL SHOULDER, OR01044C, Item Number 880435003
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. - regard BASIC NEURO, NU00259R, Item Number 800021018
FDA Device · Class II · 2022-11-30 · Roi Cps
Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.