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.
Philips is recalling the IntelliVue Patient Monitor MX400 due to a potential issue where alarms may fail to sound. The recall affects approximately 1.9 million units distributed worldwide.
GET TESTED INTERNATIONAL AB's Liver Test was distributed nationwide without FDA premarket approval or clearance. All lots are being recalled due to unapproved distribution.
GET TESTED INTERNATIONAL AB is recalling its H. pylori (Peptic Ulcer) Test distributed in the US because it was distributed without FDA premarket approval or clearance. The test was not verified for safety and effectiveness by the FDA before distribution.
GET TESTED INTERNATIONAL AB is recalling the Neurotransmitters Basic medical device for distribution without FDA premarket approval. The device was marketed nationwide without required regulatory clearance.
GET TESTED INTERNATIONAL AB is recalling 4,081 units of an Epstein-Barr Virus test that was distributed nationwide without FDA premarket approval. The recall affects all lots of this diagnostic test.
Philips is recalling IntelliVue MP90 patient monitors worldwide due to a potential issue where monitors may fail to activate alarms, preventing healthcare providers from receiving critical patient alerts.
A sperm test from GET TESTED INTERNATIONAL AB (33 units, nationwide US distribution) was recalled for being distributed without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB distributed 76 units of its Allergy test Small product nationwide without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB recalled a Candida Test distributed nationwide without FDA premarket approval or clearance. Consumers should stop using the product and consult their healthcare provider.
GET TESTED INTERNATIONAL AB's Parasite Test is being recalled because it was distributed without required FDA premarket approval or clearance. All 94 units distributed nationwide should not be used.
Philips is recalling 1.9 million IntelliVue MP30 patient monitors worldwide due to a potential issue where monitors did not alarm, which could prevent healthcare providers from receiving alerts.
Baxter Healthcare is recalling Welch Allyn replacement bladders for two-piece blood pressure cuffs due to incorrect sizing. Some kits may contain a Large Adult bladder instead of the intended Thigh size, potentially resulting in inaccurate blood pressure readings.
GET TESTED INTERNATIONAL AB is recalling the Organic Acids Profile Test Large because it was distributed in the United States without FDA premarket approval or clearance. All lots are affected.
Alcohol saliva test from GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval or clearance. The device's safety and accuracy were never verified before market distribution.
Philips is recalling IntelliVue Patient Monitor MX700 units due to a potential issue where monitors may fail to alarm. The recall affects approximately 1.9 million units distributed worldwide.
GET TESTED INTERNATIONAL AB recalled its Urinary Tract Infection Test because the device was distributed without FDA premarket approval or clearance. No illnesses have been reported.
GET TESTED INTERNATIONAL AB is recalling the Lactose Intolerance Test due to distribution without FDA premarket clearance. The product was distributed nationwide without required regulatory approval.
Philips is recalling IntelliVue Patient Monitor MX850 due to potential alarm failures affecting 1.9 million units worldwide.
GET TESTED INTERNATIONAL AB recalled its 8 in 1 STI Test Kit after distributing 2043 units nationwide without FDA premarket approval or clearance. The unapproved device poses a risk of unreliable or inaccurate test results.
Akkermansia Test, manufactured by GET TESTED INTERNATIONAL AB, was distributed nationwide without required FDA premarket approval. All lot numbers are affected.
Siemens recalls the MAMMOMAT Inspiration operator table due to improper inclusion of a bus-installation kit. The table is designed for stationary operation only and cannot be safely used on buses.
Philips IntelliVue MP2 patient monitors may fail to produce alarms under certain conditions. The recall affects approximately 1.9 million units distributed worldwide to healthcare facilities.
Allergy Test Small was distributed without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider for proper allergy testing.
GET TESTED INTERNATIONAL AB is recalling 55 units of the SIBO Test distributed nationwide in the US because the product was marketed without FDA premarket approval or clearance.
Philips IntelliVue MP50 patient monitors may fail to generate clinical alarms, prompting a recall. The affected monitoring equipment could fail to alert healthcare staff to patient conditions requiring intervention.
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