Resource Optimization & Innovation Recalls Robotic Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 30 sterile robotic hysterectomy 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 and involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 30 sterile robotic hysterectomy surgical kits (Item Number 800567001, Lot number 24243). The kits are custom procedure trays containing 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, potentially compromising the sterility of the product.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using these specific kits and contact the recalling firm for instructions on return or replacement. Do not use the kits if the equipment glove component shows signs of damage.
The recalled product
- Product
- regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 30
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 (1)
- Lot number 24243.
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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