ROi CPS LLC
ROi CPS LLC appears in FDA public data with 86 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1047-2025, Class I) was initiated on Dec 26, 2024.
Summary
- Total Recalls
- 86 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1047-2025 | Class I | regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. | Dec 26, 2024 |
| Z-3159-2024 | Class II | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 | Jul 24, 2024 |
| Z-2685-2024 | Class II | Regard Kit containing the Microtek decanter | Jun 17, 2024 |
| Z-0620-2024 | Class I | regard Operative LAP, Item Number 800943001; surgical convenience kit | Dec 18, 2023 |
| Z-0596-2024 | Class I | Regard Dressing change kit, Item Number 800026006 | Nov 20, 2023 |
| Z-0315-2024 | Class II | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit | Sep 21, 2023 |
| Z-0070-2024 | Class II | GS0008 2Y - Burn Pack - STL, Item Number 880082025 | Sep 11, 2023 |
| Z-1435-2023 | Class II | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pa | Mar 22, 2023 |
| Z-1438-2023 | Class II | Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/ | Mar 22, 2023 |
| Z-1434-2023 | Class II | Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath. | Mar 22, 2023 |
| Z-1432-2023 | Class II | Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. | Mar 22, 2023 |
| Z-1436-2023 | Class II | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. | Mar 22, 2023 |
| Z-1433-2023 | Class II | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack | Mar 22, 2023 |
| Z-1431-2023 | Class II | Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscop | Mar 22, 2023 |
| Z-1437-2023 | Class II | Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy | Mar 22, 2023 |
| Z-0286-2023 | Class II | regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit | Oct 20, 2022 |
| Z-0300-2023 | Class II | regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit | Oct 20, 2022 |
| Z-0297-2023 | Class II | regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit | Oct 20, 2022 |
| Z-0305-2023 | Class II | ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit | Oct 20, 2022 |
| Z-0284-2023 | Class II | regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit | Oct 20, 2022 |