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.
Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.
Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
TrueDent Magenta dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 94 units are affected.
Preat Astra EV-compatible 4.2 mm Digital Analogs are being recalled because a manufacturing error left the digital analog rotational feature 180 degrees off. 44 units are affected.
TrueDent White dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 109 units are affected.
Canturio Smart Extension CSE Implants are being recalled due to a labeling error, with the product incorrectly labeled. 106 units are affected.
TrueDent Clear dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 78 units are affected.
TrueDent Cyan dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 100 units are affected.
TrueDent Yellow dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 68 units are affected.
The Hummingbird Stimulated EMG Kit is being recalled because the product packaging contains the wrong part number and kit contents. 10 units are affected.
Philips Ultrasound, Inc is recalling 5,230 Philips 3D9-3v Transducer devices because they were refurbished beyond their useful life, posing a risk of device failure during medical use.
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.
The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.
The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.
Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.
Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.
Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.
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