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.
GE Medical Systems Israel is recalling 38 MAXXUS systems because units past end of guaranteed service may have been moved without adequate detector support, risking a detector fall.
Philips Medical Systems Nederland is recalling 990 Azurion R3.0 systems over nine identified software issues, including loss of X-ray after a pedal tap and continuous restart.
Boston Scientific is recalling 21 Coyote over-the-wire PTA balloon dilatation catheters over the potential for inflation and deflation difficulty during use in the peripheral vasculature.
Repligen is recalling 33 MAVERICK Measurement Module Spectrometers because cable faults can drive laser output to about 1,600 mW or falsely signal a fire command.
ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.
ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.
Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.
Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.
Heraeus Medical is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 12 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.
Hangzhou Bever Medical Devices is recalling 149,310 BD Ready-to-Use Hydrophilic Catheters, 14 Fr, over a labeling error giving an incorrect expiration date.
Philips Medical Systems Nederland is recalling 8 units of the Allura Xper FD20/20, model 722038, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 96 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 1725 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Medline is recalling 5314 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Heraeus Medical is recalling PALACOS R pro 40 and PALACOS R pro 80 bone cement because a combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Medline is recalling 33 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Philips Medical Systems Nederland is recalling 12 units of the Allura Xper FD10F, model 722002, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 21 units of the Allura Xper FD10/10, model 722011, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 93 units of the Allura Xper FD10, model 722003, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 14 units of the Allura Xper FD10/10, model 722005, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.
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