Agency classClass IIOur severity:High FDA (Devices)·Z-1614-2017·Announced 2017-04-05

Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Splitting

Resource Optimization & Innovation LLC is recalling 70 sterile total knee 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 can break the sterile field, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 70 kits of Regard sterile total knee procedure trays (Item Number: 800553002, OR0642B). The recall involves trays distributed to Medical Center Santa Rosa in California and Texas.

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 product has the code 034869B and an expiration date of April 30, 2018. Healthcare facilities should stop using these trays and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product: Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Trays
Hazard: sterile-field-breach
infection-risk
Affected units: 70

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)

034869B Exp Date 2018-04-30

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