Is REGARD Basic Cataract tray recalled?

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. Status: Voluntary: Firm initiated Initial Firm Notification: E-Mail Distribution: US Nationwide in the states of FL, LA and MO.

Medium RiskFDA Device

ROi CPS LLC: 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.

Agency Publication Date: November 18, 2021

Affected Products

Product: REGARD Basic Cataract tray

Lots numbers: 88797G, 88392G, 87844G, 86422G and 83645F

Product: REGARD Core Biopsy Tray

Lots numbers: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C

Product: REGARD Ear Tray

Lots numbers: 88400C, 87798C, 86311C and 88537C

Product: REGARD Newborn Tray

Lot number: 86453F

Lot Numbers:

number

Product: REGARD Stereotactic Tray

Lots numbers: 81985C, 80891C and 80379C

Product: REGARD Ultrasound Tray

Lots numbers: 87414C, 87035C, 86918C, 88755C and 85539C

Product: REGARD Vitrectomy Tray

Lots numbers: 89042C and 85120B

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88463

Status: Resolved

Manufacturer: ROi CPS LLC

Manufactured In: United States

Units Affected: 7 products (126 trays; 1,200 trays; 44 trays; 12; 175 trays; 240 trays; 22 trays)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.