Agency classClass IIOur severity:High FDA (Devices)·Z-1655-2017·Announced 2017-04-05

FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

Resource Optimization & Innovation LLC is recalling 288 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. The hazard involves breaking the sterile field, which poses a risk of infection, but the source text does not report any hospitalizations, serious injuries, or deaths, aligning with the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 288 kits of Regard Robotic Hysterectomy Pk - Spohn (Item Number: 800416001). The recall is being conducted by Resource Optimization & Innovation LLC. The affected kits were distributed in the United States to locations in Louisiana and Texas.

The recall is necessary because the custom procedure trays contain a light glove component that has been recalled by the manufacturer. This component can split during application to a light handle, which breaks the sterile field. The affected lots have expiration dates ranging from October 16, 2017, to March 2, 2018.

Healthcare facilities and consumers who possess these specific kits should stop using them immediately. The recall is classified as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
infection-risk
Affected units: 288

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)

028912A Exp Date 2017-10-16
030725A Exp Date 2018-01-08
031994A Exp Date 2018-03-02
033625A Exp Date 2018-02-20

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 →

Same manufacturer · Resource Optimization & Innovation Llc

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Same hazard · sterile field breach