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 216 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 32 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 92 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 209 sterile custom procedure trays because a light glove component can split during use, 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 eight sterile total knee procedure trays because a light glove component can split during use, potentially 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.
Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 14 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 228 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 344 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 78 sterile laparotomy kits because a light glove component may split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits 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 249 sterile robotic hysterectomy kits 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 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 180 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because the included light gloves 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 36 sterile arthroscopy kits 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.