Agency classClass IIOur severity:Severe FDA (Devices)·Z-1561-2017·Announced 2017-04-05

FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the defect involves breaking the sterile field, which poses a significant risk of infection or injury, aligning with the 'Severe' criteria for structural defects or significant injury risks.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 42 sterile custom procedure trays manufactured by Resource Optimization & Innovation LLC. The affected product is identified as Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU, with an expiration date of October 11, 2018, and code 038795C.

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 medical procedures. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The affected units were distributed in the United States to locations in Louisiana and Texas. Healthcare facilities and consumers who possess these specific trays should stop using them immediately and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
infection-risk
Affected units: 42

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 (1)

038795C Exp Date 2018-10-11

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