Recall of Custom Procedure Trays Due to Splitting Light Glove Component
Resource Optimization & Innovation Llc is recalling 12 custom procedure trays because a light glove component can split, breaking the sterile field.
What this means for you
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 sterile medical device where a defect breaks the sterile field, creating a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation Llc is recalling 12 custom procedure trays, identified as Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa. 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 compromises the sterility of the procedure tray. The affected units have an expiration date of 2018-06-25 and code 034595B.
The recalled trays were distributed in the United States to locations in California (LA) and Texas (TX). Users should stop using these trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 12
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)
- 034595B Exp Date 2018-06-25
Distribution
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 →Related recalls
Same manufacturer · Resource Optimization & Innovation Llc
See all →- HighFDA recalls Regard IV Start Kit component over safety issue
FDA (Devices) · 2022-04-27
- ModerateResource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
FDA (Devices) · 2020-08-05
- HighResource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects
FDA (Devices) · 2020-06-24
- ModerateResource Optimization Recalls Regard Custom Surgical Packs Due to Label Error
FDA (Devices) · 2017-11-29
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08