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.
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.
Heraeus Medical is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Philips Medical Systems Nederland is recalling 22 units of the Allura Xper FD10/10, model 722027, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 38 Allura Xper FD10C systems because the drip tray beneath the cooling unit may not have been installed.
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.
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20 OR Table, model 722023, because the drip tray beneath the cooling unit may not have been installed.
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.
Medline is recalling 32 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 8 units of the Allura Xper FD20/20, model 722038, 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.
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 3045 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 12,584 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.
Philips Medical Systems Nederland is recalling 23 units of the Allura Xper FD20 Biplane, model 722013, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 1457 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
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 2 Allura Xper FD20 systems 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 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 633 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 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.
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