FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 660 sterile 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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 660 kits of sterile custom procedure trays, identified as Regard Item Number 800326002 (GS0757B - Major Basin - OSU). 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. This failure can break the sterile field, which is a critical safety requirement for medical procedures. The affected products were distributed in the United States to locations in Louisiana and Texas.
The recalled items have specific lot codes and expiration dates: 037658B (Exp 2018-08-26), 038468B (Exp 2018-09-26), and 040771B (Exp 2018-12-28). Healthcare facilities and consumers should stop using these trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 660
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)
- 037658B Exp Date 2018-08-26
- 038468B Exp Date 2018-09-26
- 040771B Exp Date 2018-12-28
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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