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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.
Terumo's CDI OneView Hematocrit/Oxygen Saturation Probe may intermittently fail to display oxygen saturation values during clinical use. When this occurs, the monitor displays dashes and triggers a yellow low-limit alarm.
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D due to an incorrect International Sensitivity Index (ISI) value printed on the outer box label. The error could affect interpretation of prothrombin time test results.
Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.
Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.
Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.
Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.
GE Healthcare Centricity imaging systems contain a security vulnerability where service login credentials can be identified. This could allow unauthorized access and potential patient data manipulation.
GE Healthcare's Centricity medical imaging software has a security vulnerability that allows service login credentials to be identified. A malicious actor could exploit this to access or manipulate patient data.
GE Healthcare recalled Centricity PACS-IW and related medical imaging software due to a security vulnerability allowing service credentials to be identified, potentially enabling unauthorized system access and patient data manipulation.
Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.
Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.
Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.
Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.
GE Healthcare Centricity Cardiology CA1000 has a security vulnerability where service login credentials can be identified, potentially allowing unauthorized access to patient data.
Stryker Spine is recalling Monterey AL Implant Inserters due to a potential defect where the gold unlock button may separate from the device, compromising its function during spinal surgery.
Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.
BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.
Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.
GE Healthcare is recalling Centricity Radiology RA600 and related imaging systems due to a security vulnerability allowing service login credentials to be identified, potentially exposing patient data to unauthorized access.
Boppli bedside blood pressure monitors for infants may not adequately detect blood pressure changes due to vibratory noise. Affected monitors should be moved to patient's foot and ventilator lines kept away from the isolette.
Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.
Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.
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