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.
A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.
The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.
Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.
Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.
Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.
Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.
Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.
Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.
Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.
Zimmer, Inc. is recalling a ceramic femoral head for hip prosthesis (Model 802802202, 22.2 mm) because product labeling does not adequately describe compatibility with certain metal femoral stems.
Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers running Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze unexpectedly during sample measurement, causing test results to be lost and delayed.
Zimmer, Inc. is recalling a ceramic femoral head hip prosthesis (Model 802602203) because product labeling lacks compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitors due to a software issue that causes an error screen when a video laryngoscope is attached to the device.
Zimmer, Inc. is recalling a ceramic hip prosthesis head because the product labeling does not adequately describe compatibility with certain femoral stems used in hip replacement surgery.
Merit Medical has updated instructions for the EsophyX Z+ fastener delivery device to provide additional information about risks associated with device over-rotation and multiple fastener deployment.
Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to risks associated with device over-rotation and multiple fastener deployment.
Zimmer, Inc. is recalling Zimmer Biomet Ceramic Head hip prostheses (Model 802802201, 22.2 mm diameter) because product labeling does not adequately provide compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
Abbott Molecular is recalling the Alinity m System due to a design flaw that may allow liquid waste or system solutions to spill beyond the instrument footprint into the user's walking path.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer may lose connection to laboratory information systems, interrupting sample processing and delaying patient test results.
Zimmer, Inc. is recalling a ceramic hip prosthesis head because its labeling does not adequately describe compatibility with cobalt-chrome or stainless-steel femoral stems.
Edge Biologicals is recalling Sterile Water, 3mL (Product Number T-0780, Lot 01223) due to incorrect labeling on the product's outer packaging. The affected units were distributed nationwide in Pennsylvania.
Straumann USA LLC is recalling 1,786 units of WB XL Anatomic Healing Abutment XC endosseous dental implant abutments due to incorrect blister labeling. The product was distributed worldwide.
ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.
Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.
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