ROi CPS LLC recall records

13 reported ongoing

68 records in this archive. Latest source date Dec 26, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

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 impa...

Class IReported ongoing

Distribution: Distribution was made to MO. There was no government/military/foreign distribution.

Official source for regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitat...
FDA device enforcement

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

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 ...

Class IIReported ongoing

Distribution: MO

Official source for Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA device enforcement

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

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparosco...
FDA device enforcement

Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Num...

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2....
FDA device enforcement

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

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
FDA device enforcement

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

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
FDA device enforcement

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

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy P...
FDA device enforcement

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

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA device enforcement

Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. rega...

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cu...
FDA device enforcement

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...

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.

Class IIReported ongoing

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

Official source for Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hi...

Reasons in these listed records

  • 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 vent...
  • Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
  • Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
  • Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

These examples come from this result page and are not a ranking of every recall reason.

Checking ROi CPS LLC

Is there a recall on roi cps llc right now?

This archive contains 68 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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