FDA Recalls 100 Neurosurgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 100 sterile neurosurgical kits because equipment glove components may have 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, and the hazard involves a risk of harm (infection due to compromised sterility) in a medical device where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 100 sterile neurosurgical kits manufactured by Resource Optimization & Innovation LLC. The affected products are identified as Item Number 800623, NU0787, and are associated with Lot number 22593. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes. These defects could compromise the sterility of the surgical instruments and accessories, posing a risk of infection to patients during use. The distribution of these kits was limited to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities and consumers who possess these specific neurosurgical kits should stop using them immediately. The responsible firm, Resource Optimization & Innovation LLC, is handling the recall. Users should contact the manufacturer or their medical supply representative for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing 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 procedure
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 100
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 number 22593.
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
- SevereFDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile Vaginal Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighRecall of Regard Custom Procedure Trays Due to Splitting Light Gloves
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighRecall of Custom Procedure Trays with Defective Light Gloves
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile Breast Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05