ROi CPS Regard Dressing Change Tray Recall: Package Integrity Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

ROi CPS is recalling Regard Dressing Change Trays with lot numbers 86983C, 870:86356C because ChloraPrep applicators in the kit can grow organisms that compromise the packaging. This could lead to contamination of the dressing change tray.

Why it’s dangerous

ChloraPrep applicators in the kit can grow organisms that weaken the packaging. This may allow contaminants to enter the dressing change tray, potentially causing infection or contamination during use.

Who’s affected

Users of Regard Dressing Change Trays with the specified lot numbers are affected. Healthcare professionals and patients using these trays for wound care are at risk if the packaging integrity is compromised.

How to tell if you have this one

Check the lot number on the Regard Dressing Change Tray packaging. The affected lot numbers are 86983C, 87081C, and 86356C.

Brand
ROi CPS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Identify the lot number on the Regard Dressing Change Tray packaging to determine if it is affected.

✎ GovInfoNow

Questions people ask

What lot numbers are affected?

Lot numbers 86983C, 87081C, and 86356C.

Why is this recall happening?

ChloraPrep applicators in the kit can grow organisms that compromise the packaging integrity.

What should I do if I have the affected lot numbers?

Check the lot number on the packaging to confirm if it is affected; no specific action is required beyond checking.

Take action

Contact ROi CPS

We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1542-2021 — ROi CPS ROi CPS

Hello,

I own a ROi CPS that is covered by recall Z-1542-2021 from ROi CPS.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1542-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1542-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

ROi CPS LLC recalls Regard Dressing Change Tray

Lower-risk recall