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 104 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 27 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays because a light glove component 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 450 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 90 sterile procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 2,122 Regard Ortho Pk Spohn custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 164 sterile vascular procedure trays because a light glove component may split during use, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 284 Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 45 sterile 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 248 sterile laparotomy procedure trays because a light glove component 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 704 sterile laparoscopic procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 54 kits of Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 420 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 372 sterile vascular procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 216 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 48 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
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 56 sterile major vaginal procedure kits because a light glove component may split during use, breaking the sterile field.
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 320 sterile C Section Packs because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 212 Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.