Agency classClass IIOur severity:High FDA (Devices)·Z-1589-2017·Announced 2017-04-05

Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

Resource Optimization & Innovation Llc is recalling 344 sterile custom 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 is classified as FDA Class II. The hazard involves a sterile field breach, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Resource Optimization & Innovation Llc is recalling 344 kits of Regard sterile custom procedure trays (Item Number: 800524003, LD0608C - C Section - Westover Hills). 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.

The affected products were distributed in the United States to locations in Louisiana and Texas. The recall includes specific lots with expiration dates ranging from November 24, 2017, to May 11, 2018.

The FDA has classified this as a Class II recall. Users should stop using the affected trays and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
infection-risk
Affected units: 344

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)

029709C Exp Date 2017-11-24
029888C Exp Date 2017-12-07
032207C Exp Date 2018-03-24
033503C Exp Date 2018-05-11

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