Agency classClass IIOur severity:High FDA (Devices)·Z-1671-2017·Announced 2017-04-05

Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

Resource Optimization & Innovation LLC is recalling 454 Regard custom procedure trays because the included light gloves can split during application, 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, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 454 kits of Regard custom procedure trays, Item Number 800430004. These sterile trays were distributed in the United States to locations in California and Texas.

The recall was initiated because the trays contain a component, a light glove, that can split during application to a light handle. This failure can break the sterile field, which is a critical safety requirement for medical procedures.

Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. The affected lots have expiration dates ranging from October 2017 to June 2018. Users should contact the manufacturer for further instructions on how to return or dispose of the product.

The recalled product

Product: Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
infection-risk
Affected units: 454

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 (5)

028544D Exp Date 2017-10-06
031310D Exp Date 2018-01-29
031515D Exp Date 2018-03-29
032531D Exp Date 2018-03-29
034656D Exp Date 2018-06-28

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