ROi CPS LLC

FDA Regulatory Profile

Summary

Total Recalls
86 (3 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1047-2025Class Iregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator.December 26, 2024
Z-3159-2024Class IIregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009July 24, 2024
Z-2685-2024Class IIRegard Kit containing the Microtek decanterJune 17, 2024
Z-0620-2024Class Iregard Operative LAP, Item Number 800943001; surgical convenience kitDecember 18, 2023
Z-0596-2024Class IRegard Dressing change kit, Item Number 800026006November 20, 2023
Z-0315-2024Class IIRegard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kitSeptember 21, 2023
Z-0070-2024Class IIGS0008 2Y - Burn Pack - STL, Item Number 880082025September 11, 2023
Z-1436-2023Class IISterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.March 22, 2023
Z-1434-2023Class IISterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.March 22, 2023
Z-1435-2023Class IISterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy PaMarch 22, 2023
Z-1433-2023Class IISterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal PackMarch 22, 2023
Z-1437-2023Class IISterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy March 22, 2023
Z-1432-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2.March 22, 2023
Z-1431-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General LaparoscopMarch 22, 2023
Z-1438-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/March 22, 2023
Z-0311-2023Class IIregard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kitOctober 20, 2022
Z-0291-2023Class IIregard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kitOctober 20, 2022
Z-0293-2023Class IIregard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kitOctober 20, 2022
Z-0300-2023Class IIregard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kitOctober 20, 2022
Z-0285-2023Class IIregard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kitOctober 20, 2022