Resource Optimization & Innovation Recalls Sterile Shoulder Surgical Kits
Resource Optimization & Innovation LLC is recalling 832 sterile shoulder 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 medical device where a defect (splits/holes in glove components) compromises sterility, posing a risk of infection. This fits 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 832 sterile shoulder surgical kits (Item Number 800415, OR0484). The kits contain surgical instruments and accessories intended for use during a surgical procedure. The recall is due to equipment glove components that may contain splits or holes, which could compromise the sterility of the kits.
The affected lots are 14976, 16518, 18233, 19212, 20544, 21138, 22231, 23249, and 24291. Distribution was made to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
Healthcare facilities and consumers should stop using these kits and contact the recalling firm for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- regard Item Number: 800415, Sterile, OR0484 - Shoulder System 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
- 832
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 (9)
- Lot numbers 14976
- 16518
- 18233
- 19212
- 20544
- 21138
- 22231
- 23249
- and 24291.
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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