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 660 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 12 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 15 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 100 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 1,548 sterile procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 150 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 26 sterile pacemaker procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 460 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 834 sterile lap chole kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 92 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 165 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 70 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 306 Spohn AV Access Kits because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 30 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 200 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 41 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 690 sterile C-section kits because a light glove component may split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 55 VP Shunt procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 16 sterile breast PK procedure kits because a light glove component can split, breaking the sterile field.