Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because the equipment 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 is classified as FDA Class II. The hazard involves compromised sterility in a medical device, which poses a risk of harm (infection) but no injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits (Item Number 800407001, OR0476A - Ortho Pk). The affected lots are 19209, 20558, and 22943. The kits contain surgical instruments and accessories intended for use during a surgical procedure.
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 kits. The distribution was made to Louisiana, Mississippi, and Texas.
The FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the recall is limited to the specified lots and distribution areas.
The recalled product
- Product
- regard Item Number: 800407001, Sterile, OR0476A - Ortho 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
- 1,476
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 19209
- 20558
- and 22943.
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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