Resource Optimization & Innovation LLC Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 72 sterile C-section 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 risk-of-harm product (sterile surgical kit) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 72 sterile C-section surgical kits, Item Number 880323, Lot numbers 20407 and 22085. The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
The affected kits were distributed to Louisiana, Mississippi, and Texas. The recall is classified as Class II by the FDA.
Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 880323, Sterile, LD0754 - C Section - 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 surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 72
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 (1)
- Lot numbers 20407 and 22085.
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
- HighResource Optimization Recalls Sterile C-Section Kits Due to Glove Defect
FDA (Devices) · 2017-04-05
- HighRecall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- SevereResource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
FDA (Devices) · 2015-11-04
- HighRecall of Regard Sterile C Section Packs Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighSterile surgical C-section kit light handle covers recalled for separation risk
FDA (Devices) · 2023-05-03