Exact FDA event identifier

Event 91984

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

Event summary

Timeline bucket: March 22, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
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

8 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 8

Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

Z-1431-2023

Recall number: Z-1431-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 278 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

1. Lot #95475, exp. 10/29/2024, UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493, exp. 9/7/2024, UDI (01)10194717112327(17)240907(10)95493.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 2 of 8

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

Z-1432-2023

Recall number: Z-1432-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 662 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

1. Lot #95322, exp. 10/29/2024, UDI (01)10194717105015(17)241029(10)95322; 2. Lot #95553, exp. 11/15/2024, UDI (01)10194717112389(17)241115(10)95553; 3. Lot #95438, exp. 10/29/2024, UDI (01)10194717110927(17)241029(10)95438; 4. Lot #95784, exp. 11/30/2024, UDI (01)10194717116837(17)241130(10)95784; 5. Lot #95767, exp. 10/29/2024, UDI (01)10194717112198(17)241029(10)95767; 6. Lot #95735, exp. 10/29/2024, UDI (01)10194717112174(17)241029(10)95735.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 3 of 8

Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

Z-1433-2023

Recall number: Z-1433-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 70 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

Lot #95437, exp. 11/15/2024, UDI (01)10194717110903(17)241115(10)95437.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 4 of 8

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

Z-1434-2023

Recall number: Z-1434-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 322 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 5 of 8

Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

Z-1435-2023

Recall number: Z-1435-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 386 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

Lot #95517, exp. 10/17/2024, UDI (01)10194717108719(17)241017(10)95517.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 6 of 8

Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

Z-1436-2023

Recall number: Z-1436-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 1,312 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

Lot #95165, exp. 10/27/2024, UDI (01)10194717116387(17)241027(10)95165; lot #95374, exp. 10/17/2024, UDI (01)10194717116387(17)241017(10)95374; and lot #95615, exp. 11/15/2024, UDI (01)10194717116387(17)241115(10)95615.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 7 of 8

Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

Z-1437-2023

Recall number: Z-1437-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 456 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

1. Lot #95370, exp. 10/29/2024, UDI (01)10194717111023(17)241029(10)95370; 2. Lot #95477, exp. 6/30/2024, UDI (01)10194717112242(17)240630(10)95477; 3. Lot #95506, exp. 5/31/2024, UDI (01)10194717114130(17)240531(10)95506; 4. Lot #95632, exp. 5/30/2024, UDI (01)10194717112709(17)240530(10)95632; and 5. Lot #95646, exp. 11/15/2024, UDI (01)10194717110880(17)241115(10)95646, and Lot #95309, exp. 10/29/2024, UDI (01)10194717110880(17)241029(10)95309.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

device · product 8 of 8

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.

Z-1438-2023

Recall number: Z-1438-2023
Initiated: March 22, 2023
Classification: Class II
Status: Ongoing
Recalling firm: ROi CPS LLC
Quantity: 1,369 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

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

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information

1. Lot #95080, exp. 9/7/2024, UDI (01)10194717114161(17)240907(10)95080; 2. Lot #95381, exp. 5/30/2024, UDI (01)10194717112341(17)240530(10)95381; 3. Lot #95516, exp. 9/30/2024, UDI (01)10194717112365(17)240930(10)95516; 4. Lot #95388, exp. 10/29/2024, UDI (01)10194717114192(17)241029(10)95388; 5. Lot #95310, exp. 10/27/2024, UDI (01)10194717112778(17)241027(10)95310; 6. Lot #95503, exp. 12/31/2023, UDI (01)10194717112150(17)231231(10)95503; 7. Lot #95667, exp. 10/29/2024, UDI (01)10194717113904(17)241029(10)95667; 8. Lot #95634, exp. 11/30/2024, UDI (01)10194717114154(17)241130(10)95634; 9. Lot #95555, exp. 11/29/2024, UDI (01)10194717111016(17)241129(10)95555; 10. Lot #95769, exp. 10/29/2024, UDI (01)10194717114185(17)241029(10)95769; 11. Lot #95422, exp. 11/30/2024, UDI (01)10194717114178(17)241130(10)95422; and 12. Lot #95633, exp. 10/17/2024, UDI (01)10194717113713(17)241017(10)95633.

Distribution pattern

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.