ROi CPS LLC recalls
28 recalls in our records from 2020 to 2025: 28 FDA medical devices.
Recalls with full detail pages
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ROi CPS LLC medical device recall: regard Item Number: 830106006
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…
Earlier and other recalls
These link to the official agency notice.
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ROi CPS LLC medical device recall: regard Clinical Packaging Solutions Official notice ↗
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
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ROi CPS LLC medical device recall: Regard Kit containing the Microtek decanter Official notice ↗
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
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ROi CPS LLC medical device recall: regard Operative LAP Official notice ↗
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
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ROi CPS LLC medical device recall: Regard Dressing change kit Official notice ↗
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
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ROi CPS LLC medical device recall: Regard CV PK Official notice ↗
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…
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ROi CPS LLC medical device recall: GS0008 2Y - Burn Pack - STL Official notice ↗
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…
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ROi CPS LLC medical device recall: Sterile surgical convenience kits: 1. regard Item Number: 880405003 Official notice ↗
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…
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ROi CPS LLC medical device recall: regard LAMINECTOMY Official notice ↗
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
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ROi CPS LLC medical device recall: Nonsterile convenience kits Official notice ↗
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
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ROi CPS LLC medical device recall: regard Item Number: 800774001 Official notice ↗
A nonsterile component was packaged in a sterile convenience kit.
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ROi CPS LLC medical device recall: regard GS0098C - RESUSABLE RT BRONCH Official notice ↗
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
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ROi CPS LLC medical device recall: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS -… Official notice ↗
Potential for the tip of the electrode to detach during use.
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ROi CPS LLC medical device recall: Regard brand CABG Pack A and B - Spartanburg Official notice ↗
Kits were packed into shipping boxes incorrectly.
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ROi CPS LLC medical device recall: Convenience kits containing regard IV Start Kits Official notice ↗
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
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ROi CPS LLC medical device recall: Regard Custom Procedure Kits containing BD Luer Lok Access Devices Official notice ↗
Recalled devices were packaged in convenience kits.
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ROi CPS LLC medical device recall: Regard Official notice ↗
Products are mislabeled with the incorrect product identification on individual kit labeling.
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ROi CPS LLC medical device recall: Regard Official notice ↗
Kits lacks rubber latex warning label.
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ROi CPS LLC medical device recall: regard Clinical Packaging Solutions Item Number 830096005 Official notice ↗
The kit contains a non-sterile needle.
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ROi CPS LLC medical device recall: REGARD Basic Cataract tray Official notice ↗
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
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ROi CPS LLC medical device recall: Regard NEWBORN KIT Official notice ↗
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
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ROi CPS LLC medical device recall: Regard Dressing Change Tray Official notice ↗
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
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ROi CPS LLC medical device recall: Regard Official notice ↗
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have…
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ROi CPS LLC medical device recall: Custom procedure packs Official notice ↗
Gauze sponges contained in custom kits may be flaking or fraying.
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ROi CPS LLC medical device recall: Regard - Product Usage: Obstetric Gynecologic specialized manual… Official notice ↗
Labeling error, incorrect expiration date.
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ROi CPS LLC medical device recall: Isolation Droplet Bundle Kit Official notice ↗
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the…
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ROi CPS LLC medical device recall: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non… Official notice ↗
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
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ROi CPS LLC medical device recall: Custom procedure packs Official notice ↗
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.