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 86 sterile Total Joint PK procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 14 kits of Regard sterile breast PK procedure trays because a light glove component can split during use, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 460 Regard Ortho PK Spohn custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 162 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 70 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 284 Regard 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 384 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 210 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 88 kits of Regard sterile procedure trays because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 32 sterile custom procedure trays because a light glove component can split and break the sterile field.
Resource Optimization & Innovation LLC is recalling 590 sterile extremity packs because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 496 sterile total joint kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 170 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 92 sterile robotic laparoscopic 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 120 sterile custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 16 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 276 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 350 Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 210 sterile abdominal procedure kits because a light glove component may split during use, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 280 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 104 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.