Agency classClass IIOur severity:High FDA (Devices)·Z-1582-2017·Announced 2017-04-05

FDA Recalls 120 Sterile Total Joint Procedure Kits Due to Glove Defect

Resource Optimization & Innovation LLC is recalling 120 sterile Total Joint Procedure Kits because a light glove component may split during use, 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Resource Optimization & Innovation LLC is recalling 120 sterile Total Joint Procedure Kits (Item Number: 800414, OR0483 - Total Joint PK - Spohn). The recall is due to a defect in a light glove component included in the trays.

The light glove can split during application to a light handle, which breaks the sterile field. This defect poses a risk of contamination during surgical procedures. The affected products have an expiration date of 2017-04-06 and were distributed to locations in California and Texas.

Healthcare facilities that have received these kits should stop using them and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as these are professional medical devices.

The recalled product

Product: Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
Manufacturer: Resource Optimization & Innovation Llc
Category: Medical Device — Surgical Kits
Hazard: sterile-field-breach
contamination
Affected units: 120

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)

024308 Exp Date 2017-04-06

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