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.
Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can pass through the locking hole during surgery, causing surgical delays.
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
Tyber Medical is recalling 115 A.L.P.S. mvX orthopedic plates because the locking screw can pass through the locking hole during surgery, causing surgical delays and inadequate fracture fixation.
Physio-Control is recalling LIFEPAK 20e defibrillator/monitor units distributed in West Virginia due to incorrect keypad installation during manufacturing. The keypad error may affect device operation.
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.
Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.
Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.
GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.
Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the locking hole during surgery, causing surgical delays.
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.
GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.
Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its locking hole during surgery, causing surgical delays.
Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.
Rece International Corp. is recalling ViaMed Alcohol Prep Pads due to lack of sterility assurance and manufacturing process deviations. The affected product was distributed in Florida.
A software bug in IntelePACS causes incorrect diagnostic value calculations on Daylight Saving Time transition dates, risking incorrect patient diagnoses.
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.
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