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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 the IntelliVue MP80 patient monitor because it may fail to generate alarms, potentially delaying critical patient care. Over 1.9 million units are affected worldwide.
Aizu Olympus recalls the Olympus OER-Elite medical device affecting 6,578 units nationwide. Customers must follow maintenance schedules and use only trained personnel for service.
GET TESTED INTERNATIONAL AB is recalling D-Dimer Test kits (1,218 units, all lots) distributed nationwide without FDA premarket approval. The unapproved test has not been reviewed by the FDA for safety and effectiveness.
The Ivenix Infusion System Large Volume Pump (Model LVP-0004) is being recalled because it may produce false occlusion alarms when used with a check valve at low infusion flow rates. Approximately 15,862 units are affected.
GET TESTED INTERNATIONAL AB is recalling its MPOX Test nationwide due to distribution without FDA premarket approval or clearance. Consumers who have purchased this test should not use it.
Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits because Test Card Lot TT241102 failed sensitivity testing, potentially resulting in false negative results that could miss blood in stool samples.
Philips has recalled 1,913,441 IntelliVue Patient Monitor MX450 units worldwide due to a potential issue where monitors may not alarm on critical patient conditions.
GET TESTED INTERNATIONAL AB is recalling its Fecal Occult Blood Test (all lots) distributed nationwide in the US without required FDA premarket approval, meaning the product's safety and effectiveness have not been verified.
Philips is recalling IntelliVue Multi Measurement Server X2 patient monitoring devices due to a potential issue where monitors may not alarm. Approximately 1.9 million units have been distributed worldwide.
GET TESTED INTERNATIONAL AB is recalling Men's Hormone Test kits distributed nationwide without FDA premarket approval or clearance. Consumers should stop using the product.
GET TESTED INTERNATIONAL AB distributed the Organic acids Test nationwide without FDA premarket approval. The Class II device is being recalled for failing to obtain required regulatory clearance before distribution.
Philips is recalling IntelliVue MP60 patient monitors due to a potential alarm failure. Approximately 1.9 million units distributed worldwide may fail to issue critical patient alerts.
A pregnancy test manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval or clearance. All lots are affected.
GET TESTED INTERNATIONAL AB's Leaky Gut Test was marketed without FDA premarket approval. The FDA initiated a recall affecting all units in nationwide distribution.
Philips IntelliVue Multi-Measurement Module X3 monitors may fail to sound critical alarms. The recall affects approximately 1.9 million units distributed worldwide.
GET TESTED INTERNATIONAL AB distributed the GI Microbiome Profile Small nationwide without FDA premarket approval. The test was not reviewed and cleared by FDA before distribution.
GET TESTED INTERNATIONAL AB's Chlamydia Test was distributed nationwide without FDA premarket approval or clearance. Users should not rely on test results and should consult a healthcare provider for proper diagnostic testing.
A 3 in 1 STI Test manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval. Consumers should stop using the product and consult their healthcare provider.
GET TESTED INTERNATIONAL AB recalls its Lyme Test diagnostic device (940 units) distributed without FDA premarket approval. The device was distributed nationwide despite lacking required regulatory clearance.
GET TESTED INTERNATIONAL AB recalled 184 Menopause FSH 2 Tests nationwide because the devices were distributed without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling the Iron Deficiency Test distributed nationwide because it was marketed without FDA premarket clearance. Consumers should stop using this unapproved device.
Illumina is recalling NextSeq 550Dx Reagent Kits due to a quality issue with flow cell gaskets that may cause leaks during DNA sequencing runs, potentially resulting in equipment malfunction and toxic substance exposure.
GET TESTED INTERNATIONAL AB is recalling a Herpes (HSV-1 & HSV-2) test distributed nationwide without FDA premarket approval. Consumers should stop using the product and consult a healthcare provider.
GET TESTED INTERNATIONAL AB is recalling its Cholesterol Test due to FDA determination that the device was distributed without required premarket approval or clearance.
Philips is recalling 1.9 million IntelliVue patient monitors due to a potential failure of the alarm function. The issue could prevent detection of patient deterioration.
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