FDA Recalls 658 Sterile Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 658 sterile surgical kits because equipment glove components 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 is classified as FDA Class II. The hazard involves compromised sterility in a medical device used during surgical procedures, which presents a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 658 sterile surgical kits, specifically the LD0274B - C Section Pack (Item Number 800036002). The recall is being conducted because the kits contain an equipment glove component which may contain splits or holes, a defect that compromises the sterility of the product.
The affected kits were distributed to locations in Louisiana, Mississippi, and Texas. The specific lot numbers involved in this recall are 15259, 16086, 17111, 18127, and 19803.
Healthcare facilities and consumers should stop using these kits immediately and contact the recalling firm for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - 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
- 658
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 15259
- 16086
- 17111
- 18127
- and 19803.
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
- HighFDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance
FDA (Devices) · 2015-11-04
- HighRecall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighResource Optimization Recalls Sterile C-Section Kits Due to Glove Defect
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile Vaginal 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