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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 is recalling approximately 1.9 million IntelliVue MP40 patient monitors that may fail to sound alarms. Affected units were distributed worldwide to healthcare facilities.
GET TESTED INTERNATIONAL AB is recalling the Intestinal Worms Test (all lots) distributed nationwide without FDA premarket approval. The device has not undergone required regulatory review.
GET TESTED INTERNATIONAL AB recalled all 60 units of its Trichomonas Vaginalis diagnostic test distributed nationwide in the US without FDA premarket approval or clearance.
Philips is recalling the IntelliVue Patient Monitor MX100 due to a potential issue where the device may not sound alarms. The recall affects approximately 1.9 million units distributed worldwide.
Medtronic Aurora EV-ICD and Clinical EV-ICD implantable defibrillators may experience delayed high-voltage therapy delivery under rare circumstances. No patient injuries have been reported.
GET TESTED INTERNATIONAL AB distributed a medical device without FDA premarket approval or clearance. The device was distributed nationwide in the United States.
GET TESTED INTERNATIONAL AB is recalling its Diabetes Test kit (ketones & glucose) because it was distributed nationwide without FDA premarket approval. Consumers should discontinue use and consult their healthcare provider.
Aizu Olympus is recalling 6,578 units of the Olympus OER-Mini medical device distributed nationwide. Customers must be informed about safety warnings, maintenance schedules, and the requirement that only trained personnel perform repairs.
Microbiologics Inc is recalling KWIK-STIK quality control kits due to labeling errors. Some units from lot 818-111-7 were packaged in containers labeled with an incorrect lot number.
Adrenal Test kits distributed nationwide by GET TESTED INTERNATIONAL AB are being recalled because they were distributed without FDA premarket approval or clearance. Users should discontinue use immediately.
GET TESTED INTERNATIONAL AB is recalling Syphilis Test kits (528 units, all lots) that were distributed nationwide without FDA approval or clearance. The device was marketed without required regulatory authorization.
The FDA has recalled the Gut Microbiome Test Mega, a medical device manufactured by GET TESTED INTERNATIONAL AB, for distribution without premarket approval or clearance. The product was distributed nationwide.
Food Sensitivity Test Small kits are recalled for distribution without FDA premarket approval or clearance. Consumers should stop using and contact the manufacturer.
Siemens is recalling MAMMOMAT Revelation mammography systems where the operator table was sold together with a bus-installation kit, despite being designed for stationary operation only.
GET TESTED INTERNATIONAL AB is recalling its Fructose Intolerance Test because the product was distributed in the United States without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB recalls its Vitamin D2 and D3 Test (EAN: 7340221709232) distributed nationwide without FDA premarket approval. All lots are affected.
GET TESTED INTERNATIONAL AB is recalling its Allergy & Food Intolerance Test (all lots) because it was distributed nationwide without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling Ovulation Test (5 tests) nationwide due to distribution without FDA premarket approval or clearance.
Aizu Olympus is notifying customers of Olympus OER-Pro devices about important safety warnings and maintenance procedures. Only trained personnel should perform repairs and maintenance.
GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test distributed nationwide without FDA premarket approval or clearance.
A drug test device (4 substances) manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket clearance. Consumers should discontinue use and consult a healthcare provider.
GET TESTED INTERNATIONAL AB's Sperm Test (EAN 7340221710221, all lots) was distributed nationwide without required FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling the Sorbitol Intolerance Test distributed nationwide because it was sold without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling 658 units of Parasite Test distributed nationwide without FDA premarket approval. The device lacks FDA validation for safety and effectiveness.
GET TESTED INTERNATIONAL AB is recalling Gut Microbiome Test Medium nationwide because the product was distributed without FDA premarket approval. Consumers should discontinue use.
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