PlainRecalls

ROi Cps LLC

Compiled from official public sources by the editorial team.

86 recalls on record · Latest: Feb 12, 2025

ROi Cps LLC Recall Insight

ROi Cps LLC appears on 86 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.085% 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 36 entries, severity tagging shows 0 critical, 35 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 36 of 36 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 (36). The date window on this page runs from Feb 5, 2020 to Nov 30, 2022.

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 Moderate Nov 30, 2022

regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

FDA Devices Moderate Nov 30, 2022

regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit

FDA Devices Moderate Nov 30, 2022

¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho 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 27, 2022

Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

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 Jun 15, 2022

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

FDA Devices Moderate May 18, 2022

Regard brand CABG Pack A and B - Spartanburg

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 Moderate May 4, 2022

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; an…

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 Dec 29, 2021

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

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

FDA Devices Moderate Nov 24, 2021

REGARD Newborn Tray

FDA Devices Moderate Nov 24, 2021

REGARD Core Biopsy Tray

FDA Devices Moderate Nov 24, 2021

REGARD Ultrasound Tray

FDA Devices Moderate Nov 24, 2021

REGARD Stereotactic Tray

FDA Devices Moderate Aug 11, 2021

Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

FDA Devices Moderate Aug 11, 2021

Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

FDA Devices Moderate Aug 11, 2021

Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

FDA Devices Moderate May 19, 2021

Regard Dressing Change Tray

FDA Devices Moderate Apr 14, 2021

Regard, Item Number 830067009, custom cardiovascular procedure kit

FDA Devices Moderate Jan 6, 2021

Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, It…

FDA Devices Moderate Dec 9, 2020

Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

FDA Devices Moderate Jul 8, 2020

Respirator Crash Cart Kit

FDA Devices Moderate Jul 8, 2020

Isolation Droplet Bundle Kit

FDA Devices Moderate Jun 17, 2020

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

FDA Devices Moderate Feb 5, 2020

Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012…

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.