PlainRecalls

ROi CPS LLC

65 recalls on record · Latest: Feb 12, 2025

ROi CPS LLC Recall Insight

ROi CPS LLC appears on 65 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.077% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 12, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 46 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 24, 2021 to Feb 12, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Feb 12, 2025

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

FDA Devices Moderate Sep 25, 2024

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

FDA Devices Moderate Aug 28, 2024

Regard Kit containing the Microtek decanter

FDA Devices Critical Jan 24, 2024

regard Operative LAP, Item Number 800943001; surgical convenience kit

FDA Devices Critical Jan 10, 2024

Regard Dressing change kit, Item Number 800026006

FDA Devices Moderate Nov 22, 2023

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

FDA Devices Moderate Oct 11, 2023

GS0008 2Y - Burn Pack - STL, Item Number 880082025

FDA Devices Moderate May 3, 2023

Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

FDA Devices Moderate May 3, 2023

Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

FDA Devices Moderate May 3, 2023

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

FDA Devices Moderate May 3, 2023

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Univ…

FDA Devices Moderate May 3, 2023

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D…

FDA Devices Moderate Nov 30, 2022

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

FDA Devices Moderate Jul 27, 2022

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

FDA Devices Moderate Jul 6, 2022

regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

FDA Devices Moderate Jun 15, 2022

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

FDA Devices Moderate May 4, 2022

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother;…

FDA Devices Moderate May 4, 2022

Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.

FDA Devices Low Apr 6, 2022

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

FDA Devices Moderate Mar 9, 2022

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

FDA Devices Moderate Jan 19, 2022

Regard, T AND A - Rogers, sterilized convenience kits

FDA Devices Moderate Nov 24, 2021

REGARD Vitrectomy Tray

FDA Devices Moderate Nov 24, 2021

REGARD Ear Tray

FDA Devices Moderate Nov 24, 2021

REGARD Basic Cataract tray

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare ROi CPS LLC with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds