thejoe ROi CPS LLC

ROi CPS LLC: 86 FDA recall reports

Every medical device recall the FDA has published for ROi CPS LLC. The fault, and how the agency graded it.

86Reports

3Class I

14Ongoing

2025-02-12Most recent

3 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	82
Class I	3
Class III	1

By year reported

Year	Reports
2020	5
2021	14
2022	52
2023	10
2024	4
2025	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenien

Z-1047-2025 · Class I · reported 2025-02-12 · Ongoing

Why it was recalled: There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Product: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Where it went: Distribution was made to MO. There was no government/military/foreign distribution.
How much: 414 kits

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Z-3159-2024 · Class II · reported 2024-09-25 · Ongoing

Why it was recalled: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Product: regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Where it went: US Nationwide distribution in the state of North Carolina.
How much: 3387 kits

Regard Kit containing the Microtek decanter

Z-2685-2024 · Class II · reported 2024-08-28 · Ongoing

Why it was recalled: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Product: Regard Kit containing the Microtek decanter
Where it went: US Nationwide distribution in the state of MO.
How much: 78 Kits

Class I

regard Operative LAP, Item Number 800943001; surgical convenience kit

Z-0620-2024 · Class I · reported 2024-01-24 · Terminated

Why it was recalled: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Product: regard Operative LAP, Item Number 800943001; surgical convenience kit
Where it went: US distribution to Louisiana
How much: 345 units

Class I

Regard Dressing change kit, Item Number 800026006

Z-0596-2024 · Class I · reported 2024-01-10 · Terminated

Why it was recalled: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Product: Regard Dressing change kit, Item Number 800026006
Where it went: US Nationwide distribution in the state of Louisiana.
How much: 1830 units

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Z-0315-2024 · Class II · reported 2023-11-22 · Ongoing

Why it was recalled: Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Product: Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Where it went: MO
How much: 134 units

GS0008 2Y - Burn Pack - STL, Item Number 880082025

Z-0070-2024 · Class II · reported 2023-10-11 · Ongoing

Why it was recalled: Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
Product: GS0008 2Y - Burn Pack - STL, Item Number 880082025
Where it went: Missouri
How much: 103 kits

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

Z-1436-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
Product: Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 1,312 kits

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

Z-1435-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
Product: Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 386 kits

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

Z-1434-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
Product: Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 322 kits

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard I

Z-1432-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
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.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 662 kits

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. r

Z-1438-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
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: 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.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 1,369 kits

Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack;

Z-1437-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
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.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 456 kits

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

Z-1431-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
Product: Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 278 kits

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

Z-1433-2023 · Class II · reported 2023-05-03 · Ongoing

Why it was recalled: 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.
Product: Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Where it went: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
How much: 70 kits

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit

Z-0310-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 228 kits

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

Z-0287-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 190 units

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

Z-0300-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 32 kits

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

Z-0291-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 69 kits

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

Z-0288-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 160 units

regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

Z-0289-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 164 units

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

Z-0320-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 24 kits

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience ki

Z-0303-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 108 kits

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

Z-0292-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 38 kits

regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

Z-0309-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 177 kits

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

Z-0294-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 170 kits

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

Z-0304-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 125 kits

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

Z-0307-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 243 kits

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

Z-0311-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 790 kits

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

Z-0297-2023 · Class II · reported 2022-11-30 · Terminated

Why it was recalled: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product: regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
Where it went: LA, MO, NC, FL
How much: 20 kits

Showing the 30 most recent of 86. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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