FDA Recalls 88 Sterile Lap Chole Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 88 sterile 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 the hazard involves compromised sterility in surgical kits, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 88 sterile surgical kits manufactured by Resource Optimization & Innovation LLC. The affected products are identified as Item Number 800560001, GS0649A - Lap Chole - surgical kits, and are intended for use during surgical procedures. The kits are distributed in the states of Louisiana, Mississippi, and Texas.
The recall is being conducted 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 contained within the kit. The specific lot number for the affected units is 24255.
Healthcare facilities and consumers who possess these specific surgical kits should stop using them immediately. The responsible firm, Resource Optimization & Innovation LLC, is managing the recall. Users should contact the manufacturer or their supplier for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - 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
- 88
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 24255.
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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