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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88463

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 10, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ROi CPS LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

REGARD Basic Cataract tray

Z-0250-2022
Recall number
Z-0250-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
126 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 2 of 7

REGARD Core Biopsy Tray

Z-0251-2022
Recall number
Z-0251-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
1,200 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 3 of 7

REGARD Ear Tray

Z-0252-2022
Recall number
Z-0252-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
44 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 4 of 7

REGARD Newborn Tray

Z-0253-2022
Recall number
Z-0253-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot number: 86453F

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 5 of 7

REGARD Stereotactic Tray

Z-0254-2022
Recall number
Z-0254-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
175 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots numbers: 81985C, 80891C and 80379C

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 6 of 7

REGARD Ultrasound Tray

Z-0255-2022
Recall number
Z-0255-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
240 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Nationwide in the states of FL, LA and MO.

device · product 7 of 7

REGARD Vitrectomy Tray

Z-0256-2022
Recall number
Z-0256-2022
Initiated
August 10, 2021
Classification
Class II
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
22 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lots numbers: 89042C and 85120B

Distribution pattern

US Nationwide in the states of FL, LA and MO.