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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.
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 is recalling 220 A.L.P.S. mvX Anatomic Lateral Fibula Plates due to complaints that the locking screw passes through the locking hole during surgery, causing surgical delays.
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.
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.
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.
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.
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No injuries have been reported.
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.
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.
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.
CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may pass through the locking hole during surgery, causing surgical delays.
CareFusion's BD Pyxis MedFlex automated medication cabinet is being recalled due to fingerprint scanner failure and overheating, posing a potential fire hazard in clinical settings.
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may pass through the locking hole during surgery instead of securing properly, causing surgical delays. The recall affects 210 units distributed nationwide.
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass through the locking hole during surgery, causing surgical delays.
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the 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.
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.
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.
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.
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.
A software bug in IntelePACS causes incorrect diagnostic value calculations on Daylight Saving Time transition dates, risking incorrect patient diagnoses.
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.
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