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ROi CPS LLC FDA Recalls
80 recalls on file across devices, 3 of them Class I and 14 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to Class IDec 26, 2024There is a potential for the Inline Controller to be using t |
| regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009Class IIJul 24, 2024Medical convenience kits were distributed with Merit syringe |
| Regard Kit containing the Microtek decanterClass IIJun 17, 2024Decanters may have pin holes and tears in sterile packaging |
| regard Operative LAP, Item Number 800943001; surgical convenience kitClass IDec 18, 2023Surgical convenience kits were manufactured with a component |
| Regard Dressing change kit, Item Number 800026006Class INov 20, 2023ROi CPS manufactured and distributed medical convenience kit |
| Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kitClass IISep 21, 2023Specific Regard kits contain the Gentige Chest Drain Product |
| GS0008 2Y - Burn Pack - STL, Item Number 880082025Class IISep 11, 2023Medical convenience kit contains Zimmer Dermatome Blades whi |
| Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.Class IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.Class IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard ItemClass IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.Class IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regarClass IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item NumberClass IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.Class IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Class IIMar 22, 2023The recalling firm was notified by their supplier that the l |
| regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kitClass IIOct 20, 2022Surgical convenience kits were distributed containing 3M sur |
| Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CClass IIJun 3, 2022Some nonsterile components that were supposed to be sterile |
| Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.Class IIJun 3, 2022Some nonsterile components that were supposed to be sterile |
| regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.Class IIMay 20, 2022A nonsterile component was packaged in a sterile convenience |
| regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003Class IIMay 3, 2022Convenience kit contained Medline Endoscopy Bedside Cleaning |
| Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle wClass IIMay 3, 2022Potential for the tip of the electrode to detach during use. |
| Regard brand CABG Pack A and B - SpartanburgClass IIMar 21, 2022Kits were packed into shipping boxes incorrectly. |
| Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LDClass IIMar 18, 2022A drug kit component was recalled by its manufacturer due to |
| Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LDClass IIMar 18, 2022A drug kit component was recalled by its manufacturer due to |
| Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121BClass IIMar 18, 2022A drug kit component was recalled by its manufacturer due to |
| Regard Custom Procedure Kits containing BD Luer Lok Access DevicesClass IIIFeb 24, 2022Recalled devices were packaged in convenience kits. |
| Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, SterileClass IIJan 13, 2022Products are mislabeled with the incorrect product identific |
| Regard, T AND A - Rogers, sterilized convenience kitsClass IINov 30, 2021Kits lacks rubber latex warning label. |
| regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.Class IINov 4, 2021The kit contains a non-sterile needle. |
| REGARD Ultrasound TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Vitrectomy TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Ear TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Stereotactic TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Newborn TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Basic Cataract trayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| REGARD Core Biopsy TrayClass IIAug 10, 2021Povidone-Iodine swabstick manufactured by PDI, Inc. recalled |
| Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.Class IIJun 14, 2021Instructions for use updated to include the following cautio |
| Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.Class IIJun 14, 2021Instructions for use updated to include the following cautio |
| Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.Class IIJun 14, 2021Instructions for use updated to include the following cautio |
| Regard Dressing Change TrayClass IIMar 26, 2021ChloraPrep applicators in the kit can grow organisms that ca |
| Regard, Item Number 830067009, custom cardiovascular procedure kitClass IIMar 4, 2021ROi CPS, LLC has become aware, through a vendor issued urgen |