FDA Recalls 164 Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 164 sterile neuro surgical 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 involves a risk of harm (sterility compromise leading to potential infection) where no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 164 sterile neuro surgical kits manufactured by Resource Optimization & Innovation LLC. The affected product is identified as Item Number 800617, NU0768 - Neuro Pk, which is a custom procedure tray containing 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 kit, posing a risk of infection to patients during use. The specific lot numbers involved in this recall are 20131, 20363, 20500, and 20641.
Distribution of the affected kits was limited to facilities in Louisiana, Mississippi, and Texas. The source text does not report any illnesses or injuries associated with this recall. Healthcare facilities and consumers who possess these specific kits should stop using them immediately and contact the manufacturer or the FDA for further instructions on return or disposal.
The recalled product
- Product
- regard Item Number: 800617, Sterile, NU0768 - Neuro 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 surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 164
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 (3)
- Lot numbers 20131
- 20363
- 20500 and 20641.
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.
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