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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.
Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.
Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.
Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.
Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.
The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.
The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.
The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.
Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.
The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.
Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.
One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.
Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, or service personnel.
Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.
Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.
SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors distributed in the U.S. due to external labels that incorrectly list the rod size.
Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.
Edwards Lifesciences is recalling 990 units of the Edwards TruWave (30 cc)/VAMP Jr Kit pressure monitoring set because the pressure tubing may detach from the blood sampling system. Healthcare facilities should discontinue use.
Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.
Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.
Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.
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