FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk
Resource Optimization & Innovation Llc is recalling 46 sterile custom 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 is classified as FDA Class II and involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 46 kits of sterile custom procedure trays manufactured by Resource Optimization & Innovation Llc. The specific product is identified as Regard, Item Number 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels. The affected lots have expiration dates of June 21, 2018, December 1, 2018, and December 8, 2018.
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.
The affected products were distributed in the United States to locations in California (LA) and Texas (TX). No specific instructions for consumers are provided in the source text, but the recall is driven by the risk of compromising sterility during use.
The recalled product
- Product
- Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 46
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 (3)
- 034433C Exp Date 2018-06-21
- 039905C Exp Date 2018-12-01
- 040125C Exp Date 2018-12-08
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.
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