FDA Recalls 114 Sterile Head and Neck Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 114 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 involves a risk-of-harm product (sterile surgical kit) where sterility is compromised, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 114 sterile surgical kits manufactured by Resource Optimization & Innovation LLC. The affected products are custom procedure trays intended for use during head and neck surgical procedures, specifically Item Number 800549, ET0638. The kits contain surgical instruments and accessories, including a cover light handle soft component.
The recall was initiated 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 during use. The affected lots are identified by lot numbers 17580, 18551, and 19510.
Distribution of the affected kits was made to facilities in Louisiana (LA), Mississippi (MS), and Texas (TX). Healthcare facilities and consumers who have these specific surgical kits should stop using them immediately and contact the recalling firm for further instructions or a return.
The recalled product
- Product
- regard Item Number: 800549, Sterile, ET0638 - Head & Neck - 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
- 114
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 17580
- 18551
- and 19510.
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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