Recall of Robotic Hysterectomy Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays because a light glove component can split, breaking the sterile field.
What this means for you
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 (glove splitting) breaks the sterile field, creating a risk of surgical site infection or other harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays (Item Number: 800567003, GY0656C - Robotic Hysterectomy - Alamo). The recall was initiated because the trays contain a light glove component that can split during application to a light handle.
This defect can break the sterile field, which is a critical safety requirement for surgical procedures. The affected products were distributed in the United States to locations in California and Texas.
The recall covers specific lots with expiration dates of July 9, 2018, September 12, 2018, and October 26, 2018. Healthcare facilities and consumers who have these specific procedure trays should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 206
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)
- 034978C Exp Date 2018-07-09
- 038090C Exp Date 2018-09-12
- 039153C Exp Date 2018-10-26
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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