Recall archive
27 recalls · page 1 of 2
Reported Feb 12, 2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 25, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Regard Kit containing the Microtek decanter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
FDA (openFDA device enforcement)
Reported Jan 24, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
Matched: Brand — Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Regard Dressing change kit, Item Number 800026006
High riskUsing this product could cause serious injury, illness or death — stop using it now.ROi CPS LLC
Matched: Brand · Reason for recall — ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component…
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not…
FDA (openFDA device enforcement)
Reported Oct 11, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being…
FDA (openFDA device enforcement)
Reported May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — 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…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 30, 2022
regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
39 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — A nonsterile component was packaged in a sterile convenience kit.
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Potential for the tip of the electrode to detach during use.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
Regard brand CABG Pack A and B - Spartanburg
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Kits were packed into shipping boxes incorrectly.
FDA (openFDA device enforcement)
Reported May 4, 2022
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — 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.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.ROi CPS LLC
Matched: Brand — Recalled devices were packaged in convenience kits.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Products are mislabeled with the incorrect product identification on individual kit labeling.
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Regard, T AND A - Rogers, sterilized convenience kits
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Kits lacks rubber latex warning label.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — The kit contains a non-sterile needle.
FDA (openFDA device enforcement)
Reported Nov 24, 2021
REGARD Basic Cataract tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand · Reason for recall — 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…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
Regard Dressing Change Tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Regard, Item Number 830067009, custom cardiovascular procedure kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand · Reason for recall — ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer…
FDA (openFDA device enforcement)
Reported Jan 6, 2021
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Gauze sponges contained in custom kits may be flaking or fraying.
FDA (openFDA device enforcement)
Reported Dec 9, 2020
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
Matched: Brand — Labeling error, incorrect expiration date.
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up