Unrated Medical device recall · FDA · Published August 10, 2021

ROi CPS Vitrectomy Tray Recall: Out of Specifications Swabstick Hazard

ROi CPS LLC recalls specific lots of Vitrectomy Trays due to povidone-iodine swabstick used in production being out of specifications.

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

🇺🇸 FDA recall #Z-0256-2022Medical device ROi CPS LLC ›

Recall notice

Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61976-roi-cps-vitrectomy-tray-recall-out-of-specifications-swabstick-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/61976-roi-cps-vitrectomy-tray-recall-out-of-specifications-swabstick-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0256-2022

Cite this page

“ROi CPS Vitrectomy Tray Recall: Out of Specifications Swabstick Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61976-roi-cps-vitrectomy-tray-recall-out-of-specifications-swabstick-hazard. Based on FDA recall #Z-0256-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0256-2022%22&limit=1).

ROi CPS LLC recalled REGARD Vitrectomy Trays due to a povidone-iodine swabstick component manufactured by PDI, Inc. being out of specifications, according to the FDA. The Food and Drug Administration announced the Class II recall on August 10, 2021.

How to tell if you have it

Brand: ROi CPS LLC
Product: REGARD Vitrectomy Tray
Lot numbers: 89042C and 85120B
Quantity: 22 trays

The hazard

The recall involves povidone-iodine swabsticks manufactured by PDI, Inc. that were out of specifications and used as components in some ROi CPS LLC products.

Context

GovInfoNow's records show ROi CPS LLC has issued 27 other recalls since January 3, 2020. Recent brand recalls include a December 26, 2024 recall of Newborn Kits for potential loss of positive pressure and a July 24, 2024 recall of Medical Convenience Kits containing recalled Merit syringes. Other recent recalls of similar products include the Medline PICC Tray DYNJ41648A (February 25, 2026), Boston Scientific EndoVive Safety PEG Kit (February 10, 2026), and Becton Dickinson Spinal Tray (April 27, 2026).

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

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide in the states of FL, LA and MO.

Recall number	Product, codes & lots	Quantity
Z-0250-2022	REGARD Basic Cataract tray; Lots numbers: 88797G, 88392G, 87844G, 86422G and 83645F	126 trays
Z-0251-2022	REGARD Core Biopsy Tray; Lots numbers: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C	1,200 trays
Z-0252-2022	REGARD Ear Tray; Lots numbers: 88400C, 87798C, 86311C and 88537C	44 trays
Z-0253-2022	REGARD Newborn Tray; Lot number: 86453F	12
Z-0254-2022	REGARD Stereotactic Tray; Lots numbers: 81985C, 80891C and 80379C	175 trays
Z-0255-2022	REGARD Ultrasound Tray; Lots numbers: 87414C, 87035C, 86918C, 88755C and 85539C	240 trays
Z-0256-2022	REGARD Vitrectomy Tray; Lots numbers: 89042C and 85120B	22 trays

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.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide in the states of FL, LA and MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Louisiana, Missouri.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Aug 10, 2021Firm started the recall
Nov 18, 2021FDA classified it Class II
Nov 24, 2021Published in FDA’s Enforcement Report
Jun 16, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/61976-roi-cps-vitrectomy-tray-recall-out-of-specifications-swabstick-hazard">ROi CPS Vitrectomy Tray Recall: Out of Specifications Swabstick Hazard (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-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.