Resource Optimization & Innovation LLC Recalls Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,144 sterile surgical kits because a glove 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 kit) where sterility is compromised, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 1,144 sterile surgical kits, identified as Item Number 800533, GS0606 - Abdominal Pk. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The affected lots are 17697, 19351, 20560, 22036, and 24025.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes, which could compromise the sterility of the product. The kits were distributed to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities should stop using the affected kits and contact the manufacturer for further instructions. Consumers are not expected to have these products in their homes, as they are intended for professional surgical use.
The recalled product
- Product
- regard Item Number: 800533, Sterile, GS0606 - Abdominal 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
- 1,144
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 (5)
- Lot numbers 17697
- 19351
- 20560
- 22036
- and 24025
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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