ROi CPS LLC: 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.

Agency Publication Date: April 25, 2023

Affected Products

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

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.

Lot Numbers:

95475

95493

Product: 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.

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.

Lot Numbers:

95322

95553

95438

95784

95767

95735

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

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

Lot Numbers:

95437

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

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

Lot Numbers:

95383

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

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

Lot Numbers:

95517

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

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.

Lot Numbers:

95165

95374

95615

Product: 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.

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.

Lot Numbers:

95370

95477

95506

95632

95646

95309

Product: 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

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.

Lot Numbers:

95080

95381

95516

95388

95310

95503

95667

95634

95555

95769

95422

95633

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91984

Status: Active

Manufacturer: ROi CPS LLC

Manufactured In: United States

Units Affected: 8 products (278 kits; 662 kits; 70 kits; 322 kits; 386 kits; 1,312 kits; 456 kits; 1,369 kits)

Agency Last Updated: October 6, 2023

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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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Affected Products

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

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.

Lot Numbers:

95475

95493

Lot Numbers:

95322

95553

95438

95784

95767

95735

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

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

Lot Numbers:

95437

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

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

Lot Numbers:

95383

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

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

Lot Numbers:

95517

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

Lot Numbers:

95165

95374

95615

Lot Numbers:

95370

95477

95506

95632

95646

95309

Lot Numbers:

95080

95381

95516

95388

95310

95503

95667

95634

95555

95769

95422

95633