FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving potential sterility compromise in surgical kits are categorized as Severe (Score 4) due to the risk of infection or injury, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 144 units of Item Number 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kits. The kits are manufactured by Resource Optimization & Innovation LLC (ROi, LLC) of St. Louis, MO. The recall is due to a defect in the equipment glove component, which may contain splits or holes that compromise the sterility of the kit.
The affected lots are 16574, 18554, and 22612. Distribution of these kits was made to facilities in Louisiana (LA), Mississippi (MS), and Texas (TX). The kits contain surgical instruments and accessories intended for use during a robotic hysterectomy procedure.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or replacement. Patients who have already had procedures using these kits should consult their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- regard Item Number: 800567, Sterile, GY0656 - 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 during a…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 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 (3)
- Lot numbers 16574
- 18554
- and 22612.
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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