FDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise
Resource Optimization & Innovation LLC is recalling 296 sterile surgical kits because an equipment glove component 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, and the hazard involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, aligning with the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 296 sterile surgical kits manufactured by Resource Optimization & Innovation LLC. The affected product is a custom procedure tray containing surgical instruments and accessories intended for use during a surgical procedure, specifically identified as Item Number 800418, GY0487 - Major Vaginal Pk.
The recall is being conducted because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical kit, posing a risk of infection to patients. The affected lots are 14888, 15851, 17266, 18655, 20404, and 22929.
Distribution of the affected kits was made to facilities in Louisiana, Mississippi, and Texas. Healthcare facilities and consumers should stop using these kits and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- regard Item Number: 800418, Sterile, GY0487 - Major Vaginal 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 296
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 (6)
- Lot numbers 14888
- 15851
- 17266
- 18655
- 20404
- and 22929.
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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