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.
Cytal Burn Matrix 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 226 units are affected.
Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.
iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.
Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.
Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.
React Health is recalling two PHOENIX 5L Oxygen Concentrators that did not meet internal quality specifications but were inadvertently distributed.
Medline is recalling one lot of Centurion Circumcision Kits that was distributed without undergoing the required sterilization process and is therefore not sterile. 640 kits are affected.
Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.
Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.
LinkBio is recalling the CORE Workstation, a component of the CORE Shoulder System, because it may display an incorrect planning date on the Start Case menu screen.
Medline is recalling a further group of NAMIC Angiographic Syringe lots because the rotating adaptor can unwind during use and disconnect from the manifold. 149,439 units are affected.
Medline is recalling CVOR Angiography Pack-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use. 3,120 kits are affected.
Medline is recalling custom manifold and cryo EP manifold kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use. 1,698 kits are affected.
Medline is recalling Robotic Pack and Uro/Gen Robotic Pack convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
Medline is recalling TAVR PACK convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 108 units are affected.
Medline is recalling NAMIC Angiographic Control Syringes because the rotating adaptor can unwind during use, causing a loose connection or full disconnection from the manifold. 192,690 units are affected.
Medline is recalling cath lab and angiography procedure packs containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect. 17,902 kits are affected.
Medline is recalling Head and Neck CDS-LF and Heart Cath Pack-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect.
Medline is recalling Minor Plastic-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold.
Medline is recalling NAMIC Angiographic Syringes across multiple sizes because the rotating adaptor can unwind during use and disconnect from the manifold. 1,752,096 units are affected.
Medline is recalling right and left heart catheterization and angiography kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect. 79,843 units are affected.
Medline is recalling Special Procedure Trays containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 762 units are affected.
Medline is recalling a further tranche of NAMIC Angiographic Syringes because the rotating adaptor can unwind during use and disconnect from the manifold. 2,630,369 units are affected.
Medline is recalling Shoulder Arthroscopy and Extremity Pack convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
Medline is recalling laparoscopic herniorrhaphy, lap and minor procedure packs containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
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