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Resource Optimization & Innovation Recalls
228 recalls on record · September 30, 2015 to April 27, 2022 · Medical Devices
Recalls by year
15
17
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 27, 2022Medical DevicesFDA
Resource Optimization & Innovation LLC recalls Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Hazard: A kit component, the PDI Prevantics Swab, was recalled.
August 5, 2020Medical DevicesFDA
Resource Optimization & Innovation LLC recalls regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indic
Hazard: The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
June 24, 2020Medical DevicesFDA
Resource Optimization & Innovation LLC recalls Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only f
Hazard: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
June 24, 2020Medical DevicesFDA
Resource Optimization & Innovation LLC recalls Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used onl
Hazard: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
November 29, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical pro
Hazard: Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
April 5, 2017Medical DevicesFDA
Resource Optimization & Innovation Llc recalls Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Hazard: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.