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.
TissueTech, Inc. is recalling 10 units of PROKERA Plus non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
Philips is recalling two IntelliVue MP2 patient monitors because speaker failures may prevent audible alarms, potentially delaying patient treatment.
TissueTech, Inc. is recalling 75 units of PROKERA Slim non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits because they do not meet stability criteria and may impact results.
Randox Laboratories is recalling four kits of the Rx Series Mg Magnesium test due to reduced linearity performance.
Shimadzu Medical Systems is recalling 115 Mobile X-Ray Systems because the adjustable handle may have improper bolts, posing a risk of harm to individuals around the device.
Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.
Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.
TissueTech, Inc. is recalling 63 units of PROKERA non-sterile biologic corneal bandages due to potential exposure to microbial contamination.
GE Healthcare is recalling 5,284 MAC VU360 Electrocardiographs because they may display incorrect patient identification or demographic information.
Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.
LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.
Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test results.
Integra LifeSciences Corp. is recalling 552 instruction manuals for the Mayfield A2000 Skull Cap to correct inaccurate illustrations.
Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.
Welch Allyn is recalling 1,009 ELI 380 Electrocardiographs because the internal radio can disconnect from the wireless access point.
Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.
Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.
Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.
Invacare is recalling 384,767 PerfectO2 V oxygen concentrators worldwide due to a defect that may cause self-extinguishing fires or cap explosions.
CME America is recalling 4,182 NeoThrive syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.
Medtronic is recalling MiniMed 640G insulin pumps because a missing solder battery connection could interrupt power. The recall covers specific serial numbers distributed in the U.S. and abroad.
CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.
Medtronic is recalling 391 MiniMed 670G insulin pumps because a missing solder battery connection could interrupt power to the device.
Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.
Looking for a different category? Browse all recalls.