Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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 16 sterile breast PK procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 30 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
Ion Beam Applications is recalling Proteus 235 proton therapy systems because the gantry can rotate even if the snout is not properly locked.
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 456 sterile extremity packs because a light glove component may split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 148 sterile custom procedure trays because a light glove component can split, breaking the sterile field.
United Orthopedic Corporation is recalling 33 UOC Femoral Drivers because the locking lever pin may deform and break, causing the device to malfunction during surgery.
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 six sterile breast procedure kits because a light glove component 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 90 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 22 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 10 kits of Regard custom procedure trays because the included light gloves 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 90 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 240 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 40 sterile procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile 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 32 kits of Regard custom procedure trays 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 12 kits of Regard sterile procedure trays because a light glove component can split during use, 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 16 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
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