ROi CPS Vitrectomy Tray Recall: Out of Specifications Swabstick Hazard

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

ROi CPS LLC is recalling two specific lots of Vitrectomy Trays because the povidone-iodine swabsticks used in their production were out of specifications. This could affect the safety and reliability of the trays during medical procedures.

Why it’s dangerous

The povidone-iodine swabsticks used in the production of these trays were out of specifications. This could lead to improper function or safety issues during medical procedures, though the exact mechanism isn't detailed in the recall.

Who’s affected

Medical professionals using the recalled lots of Vitrectomy Trays for eye surgery are most at risk. Patients undergoing surgery with these trays could face potential safety issues.

How to tell if you have this one

Check the lot numbers on the Vitrectomy Tray: 89042C and 85120B. These specific lots were affected by the out of specifications swabsticks.

Brand
ROi CPS LLC
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your Vitrectomy Tray has lot numbers 89042C or 85120B.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The povidone-iodine swabsticks used in the production of these trays were out of specifications.

What should I do if I have the recalled product?

Check the lot numbers on your Vitrectomy Tray. If it has lot numbers 89042C or 85120B, contact ROi CPS LLC for further instructions.

Is there a risk of injury from this product?

The recall states the swabsticks were out of specifications, but the exact risk mechanism isn't detailed in the official notice.

Take action

Contact ROi CPS LLC

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

✉️ Open in email

Subject: Recall Z-0256-2022 — ROi CPS LLC ROi CPS LLC

Hello,

I own a ROi CPS LLC that is covered by recall Z-0256-2022 from ROi CPS LLC.

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-0256-2022 (August 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0256-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 Vitrectomy Tray

Recall notice