FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk
Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.
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 the hazard involves breaking the sterile field during surgery, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 236 kits of Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo. The recall is being conducted by Resource Optimization & Innovation LLC. The affected products were distributed in the United States to locations in Louisiana and Texas.
The recall is necessary because the custom procedure trays contain a component, specifically a light glove, that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. Breaking the sterile field during a surgical procedure poses a risk of infection to the patient.
Healthcare facilities that have received these kits should stop using them immediately and contact the recalling firm for instructions on how to return or dispose of the products. Patients who have already undergone procedures using these kits should contact their healthcare provider if they have concerns about potential infection.
The recalled product
- Product
- Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 236
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 (4)
- 026403B Exp Date 2017-07-13
- 029909B Exp Date 2017-12-08
- 031012B Exp Date 2018-01-18
- 031963B Exp Date 2018-03-01
Distribution
Part of a larger recall action
This product is one of 135 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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