Resource Optimization & Innovation Llc
Complete recall history across all FDA and CPSC categories — 228 total recalls
Resource Optimization & Innovation Llc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (228)
FDA medical device enforcement actions by Resource Optimization & Innovation Llc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 28, 2022 | Regard IV Start Kit for preparing and/or dressing a peripheral vein intraveno... | A kit component, the PDI Prevantics Swab, was recalled. | Class II |
| Jun 17, 2020 | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 33557... | The firm received reports from customer that the Regard Migrating Indicator s... | Class II |
| May 4, 2020 | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline... | There is a potential for the product to exhibit holes in the packaging, which... | Class II |
| May 4, 2020 | Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Fl... | There is a potential for the product to exhibit holes in the packaging, which... | Class II |
| Sep 25, 2017 | Regard Custom Surgical Pack Packs contain surgical instruments and accesso... | Resource Optimization & Innovation, LLC (ROi) received a recall notice from B... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Sant... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center ... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Children... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St F... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Sant... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Sa... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover ... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - ... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical C... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Chil... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens S... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Sa... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Sa... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover ... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Cent... | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
| Jan 9, 2017 | Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn | Custom procedure trays contain a component, a light glove, that has been reca... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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