thejoe Resource Optimization & Innovation Llc

Resource Optimization & Innovation Llc: 228 FDA recall reports

Every medical device recall the FDA has published for Resource Optimization & Innovation Llc. The fault, and how the agency graded it.

228Reports

0Class I

1Ongoing

2022-04-27Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	228

By year reported

Year	Reports
2015	88
2017	136
2020	3
2022	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Z-0950-2022 · Class II · reported 2022-04-27 · Terminated

Why it was recalled: A kit component, the PDI Prevantics Swab, was recalled.
Product: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Where it went: US distribution to two consignees located in Missouri
How much: 3,570 kits

regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integra

Z-2699-2020 · Class II · reported 2020-08-05 · Terminated

Why it was recalled: 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.
Product: regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
Where it went: US Nationwide distribution including in the states of MO, NC, AR, OK.
How much: 66 cases of 12,000 units per case

Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be u

Z-2369-2020 · Class II · reported 2020-06-24 · Terminated

Why it was recalled: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Product: Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Where it went: US Nationwide distribution including in the states of MO, NC.
How much: 12,640 units

Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to b

Z-2368-2020 · Class II · reported 2020-06-24 · Terminated

Why it was recalled: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Product: Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Where it went: US Nationwide distribution including in the states of MO, NC.
How much: 9,360 units

Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a su

Z-0169-2018 · Class II · reported 2017-11-29 · Ongoing

Why it was recalled: 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.
Product: Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Where it went: Distributed domestically to Texas.
How much: 51 units

Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

Z-1594-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
Where it went: US Distribution to LA and TX.
How much: 15 kits

Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn

Z-1654-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Where it went: US Distribution to LA and TX.
How much: 208 kits

Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa

Z-1611-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 100 kits

Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn

Z-1646-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Where it went: US Distribution to LA and TX.
How much: 274 kits

Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo

Z-1631-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
Where it went: US Distribution to LA and TX.
How much: 206 kits

Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU

Z-1562-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
Where it went: US Distribution to LA and TX.
How much: 1,548 kits

Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa

Z-1608-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 209 kits

Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa

Z-1623-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 150 kits

Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa

Z-1628-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 384 kits

Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU

Z-1568-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
Where it went: US Distribution to LA and TX.
How much: 26 kits

Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa

Z-1546-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 210 kits

Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

Z-1599-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
Where it went: US Distribution to LA and TX.
How much: 460 kits

Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

Z-1651-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Where it went: US Distribution to LA and TX.
How much: 164 kits

Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini

Z-1672-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Where it went: US Distribution to LA and TX.
How much: 212 kits

Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn

Z-1551-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
Where it went: US Distribution to LA and TX.
How much: 112 kits

Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels

Z-1545-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Where it went: US Distribution to LA and TX.
How much: 46 kits

Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU

Z-1567-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Where it went: US Distribution to LA and TX.
How much: 28 kits

Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

Z-1598-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
Where it went: US Distribution to LA and TX.
How much: 834 kits

Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels

Z-1555-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
Where it went: US Distribution to LA and TX.
How much: 88 kits

Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn

Z-1658-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Where it went: US Distribution to LA and TX.
How much: 92 kits

Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

Z-1673-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 30 kits

Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa

Z-1619-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
Where it went: US Distribution to LA and TX.
How much: 356 kits

Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

Z-1549-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
Where it went: US Distribution to LA and TX.
How much: 208 kits

Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper

Z-1670-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Where it went: US Distribution to LA and TX.
How much: 32 kits

Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

Z-1652-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: 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.
Product: Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
Where it went: US Distribution to LA and TX.
How much: 496 kits

Showing the 30 most recent of 228. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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