Resource Optimization & Innovation Recalls Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 500 sterile vascular surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where a defect (splits/holes in the glove component) compromises sterility, creating a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, which aligns with a High severity rating for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 500 sterile vascular surgical kits (Item Number 800413001, CV0482A). The kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures. The recall was initiated because the kits contain an equipment glove component which may contain splits or holes, potentially compromising the sterility of the device.
The affected lots are 19412, 19858, 22464, 23253, and 24066. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement. Patients who have had procedures using these kits should consult their healthcare provider if they have concerns about potential sterility compromise.
The recalled product
- Product
- regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers 19412
- 19858
- 22464
- 23253
- and 24066.
Distribution
Part of a larger recall action
This product is one of 77 recalled by Resource Optimization & Innovation Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 77 products in this recall →Related recalls
Same manufacturer · Resource Optimization & Innovation Llc
See all →- HighFDA recalls Regard IV Start Kit component over safety issue
FDA (Devices) · 2022-04-27
- ModerateResource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
FDA (Devices) · 2020-08-05
- HighResource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard Custom Surgical Packs Due to Label Error
FDA (Devices) · 2017-11-29
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereResource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls 28 Custom Cardiovascular Surgical Kits
FDA (Devices) · 2015-11-04
- HighResource Optimization Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighRecall of Regard Vascular Procedure Trays Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighResource Optimization & Innovation Recalls Sterile Breast PK Procedure Trays
FDA (Devices) · 2017-04-05
- HighRecall of Sterile Arthroscopy Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05