Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 24 sterile surgical kits because a component 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 involves a risk-of-harm product (sterile surgical kits) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 24 sterile surgical kits, identified by Item Number 800597 and Lot number 16925. These custom procedure trays, labeled as GY0688 - LAVH, contain surgical instruments and accessories intended for use during surgical procedures. The recall is due to a defect in an equipment glove component, which may contain splits or holes that compromise the sterility of the kits.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have these specific surgical kits should stop using them immediately and contact the recalling firm for instructions on return or replacement. Do not use the kits for any surgical procedure until the issue is resolved.
The recalled product
- Product
- regard Item Number: 800597, Sterile, GY0688 - LAVH - 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
- 24
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 16925.
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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