Unrated Medical device recall · FDA · Published November 20, 2023

ROi CPS Regard Dressing Kit Recall: Irrigation Solution Component Issue

ROi CPS recalls Regard Dressing change kits with specific item numbers due to irrigation solution component issues. Affected kits may have safety concerns.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0596-2024Medical device ROi CPS ›

Recall notice

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Take action

Contact the company

Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758

✎ GovInfoNow plain-language explainer

ROi CPS is recalling Regard Dressing change kits with item number 800026006 because the irrigation solution component was recalled by its manufacturer. This could pose safety risks if the component fails. Read more at govinfonow.com/recall/56789-roi-cps-regard-dressing-kit-recall-irrigation-solution-component-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/56789-roi-cps-regard-dressing-kit-recall-irrigation-solution-component-issue · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0596-2024

Cite this page

“ROi CPS Regard Dressing Kit Recall: Irrigation Solution Component Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56789-roi-cps-regard-dressing-kit-recall-irrigation-solution-component-issue. Based on FDA recall #Z-0596-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2024%22&limit=1).

The FDA announced on 2023-11-20 that ROi CPS LLC is recalling the Regard Dressing change kit, Item Number 800026006. The recall was initiated because the product contained an irrigation solution component subsequently recalled by its manufacturer.

How to tell if you have it

Brand: ROi CPS
Product: Regard Dressing change kit
Item Number: 800026006
UDI/DI: 10194717107873
Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Quantity: 1830 units

The hazard

According to the FDA, ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. The recall is classified as Class I.

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since 2020-01-03. Recent brand recalls include a 2024-12-26 Newborn Kit Recall for risk of ineffective ventilation, a 2024-07-24 recall of medical convenience kits with Merit syringes, and a 2024-06-17 Regard Kit Microtek Decanter Recall for pin holes in sterile packaging. Other recent recalls of similar products include Medline Medical Procedure Kits Recalled on 2025-12-16 and Medline convenience kits recalled on 2026-07-10.

How to tell if you have this one

Check for the item number 800026006 on the kit. Affected kits have lot numbers including 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, or 94270.

Brand
ROi CPS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the item number and lot numbers on the kit to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of Louisiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

Nov 20, 2023Firm started the recall
Jan 3, 2024FDA classified it Class I
Jan 10, 2024Published in FDA’s Enforcement Report
Aug 5, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More ROi CPS recalls

Link to this recall

<a href="https://govinfonow.com/recall/56789-roi-cps-regard-dressing-kit-recall-irrigation-solution-component-issue">ROi CPS Regard Dressing Kit Recall: Irrigation Solution Component Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0596-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0596-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.