Lower risk Medical device recall · FDA · Published March 22, 2023

ROi CPS Surgical Kit: Light Handle Covers May Fall Off During Use

ROi CPS recalls sterile surgical convenience kits (Item 800706005, LD0091E) where light handle covers may detach during use. Affected lots expire by October 2024.

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

🇺🇸 FDA recall #Z-1436-2023Medical device ROi CPS ›

Lower-risk 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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

ROi CPS is recalling sterile surgical convenience kits that may have light handle covers that fall off during use. This could lead to the kit becoming unsafe for medical procedures. Read more at govinfonow.com/recall/58670-roi-cps-surgical-kit-light-handle-covers-may-fall-off.

Source Summary by GovInfoNow · govinfonow.com/recall/58670-roi-cps-surgical-kit-light-handle-covers-may-fall-off · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1436-2023

Cite this page

“ROi CPS Surgical Kit: Light Handle Covers May Fall Off During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58670-roi-cps-surgical-kit-light-handle-covers-may-fall-off. Based on FDA recall #Z-1436-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2023%22&limit=1).

ROi CPS LLC is recalling Sterile surgical convenience kits due to light handle covers that may separate during use, the FDA announced on March 22, 2023. The recall affects 1,312 kits distributed in Florida and Missouri.

How to tell if you have it

Brand: ROi CPS
Product: Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack
UPC: 10194717116387
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
Lot #95615, exp. 11/15/2024, UDI (01)10194717116387(17)241115(10)95615

The hazard

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

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since 2020-01-03. Recent brand recalls include a Newborn Kit recall on 2024-12-26 for risk of ineffective ventilation, a Medical Convenience Kit recall on 2024-07-24 involving Merit syringes, and a Regard Kit Microtek Decanter recall on 2024-06-17 for pin holes in sterile packaging. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (2025-12-04), Merit Medical Custom Inflation Kit (2025-12-04), and Merit Medical Custom Manifold Kit Recall (2025-12-04).

How to tell if you have this one

Check for the kit's item number 800706005 and model LD0091E. The affected lots have expiration dates by October 2024 (lots 95165, 95374, and 95615).

Brand
ROi CPS
Product
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack
Category
Medical device

FDA recall event · 8 products

All 8 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
Ongoing
Distribution
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

Recall number	Product, codes & lots	Quantity
Z-1431-2023	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.	278 kits
Z-1432-2023	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.	662 kits
Z-1433-2023	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.	70 kits
Z-1434-2023	Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.; Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383.	322 kits
Z-1435-2023	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.	386 kits
Z-1436-2023	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.	1,312 kits
Z-1437-2023	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.	456 kits
Z-1438-2023	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.; 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.	1,369 kits

Based on the official FDA remedy

What to do — step by step

Check Kit Expiration
Verify the expiration date on the kit's label; affected lots expire by October 2024.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Missouri.

Recall timeline

FDA published this recall 42 days after the firm started it.

Mar 22, 2023Firm started the recall
Apr 25, 2023FDA classified it Class II
May 3, 2023Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More ROi CPS recalls

Link to this recall

<a href="https://govinfonow.com/recall/58670-roi-cps-surgical-kit-light-handle-covers-may-fall-off">ROi CPS Surgical Kit: Light Handle Covers May Fall Off During Use (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-1436-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1436-2023 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.