FDA (Devices) recall action 76255
The FDA (Devices) publishes a recall like this one as 135 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 135 pages.
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Resource Optimization & Innovation LLC is recalling 96 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 46 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 42 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 290 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling six sterile breast procedure kits because a light glove component can split, breaking the sterile field.
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.
Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 670 sterile C Section Packs because a light glove component can split, potentially breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 90 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.