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 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 96 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy 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.
National Biological Corp is recalling seven Hand Foot II, UVB-138 phototherapy devices because wiring defects may allow lamps to turn on with the key switch rather than the timer.
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 71 custom procedure trays because a light glove component can split, breaking the sterile field.
Hospira is recalling 62,847 Plum 360 Infusion Pumps with software version 15.02 due to a defect that causes therapy to stop and incorrect alarms to display.
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 356 Regard custom procedure trays 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 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.
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 290 sterile abdominal procedure trays 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 840 sterile 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 118 Spohn AV Access Procedure Kits because a light glove component may split during use, 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 148 sterile vaginal kits because a light glove component may split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 25 sterile custom procedure trays because a light glove component can split during application, 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.
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