Agency classClass IIOur severity:High FDA (Devices)·Z-1631-2017·Announced 2017-04-05

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.

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 (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
Hazard: sterile-field-breach
infection-risk
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

Distributed in 2 states:

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.

See all 135 products in this recall →

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Same hazard · sterile field breach