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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.
Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.
Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.
Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.
Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.
Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.
Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.
Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.
GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.
Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.
GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.
GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.
Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.
Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.
GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.
GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.
Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.
GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.
Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were distributed nationwide.
GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.
Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.
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