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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.
Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.
Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.
Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.
Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.
Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.
Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.
Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.
Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.
Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.
Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.
Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.
Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.
Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.
Coloplast is recalling 13 units of the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis due to decreased wall thickness that could cause premature pump failure.
The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.
Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.
Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.
Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.
Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.
Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.
Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.
Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.
Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.
Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.
Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.
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