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.
GE Medical Systems is recalling certain Senographe mammography systems due to missing or incorrect X-Ray warning labels. The recall affects approximately 1,818 units globally.
Orthofix U.S. LLC recalls FIREBIRD SI Fusion System surgical screws due to labeling claims that are not consistently present. All 19,431 units distributed worldwide are affected.
Cardinal Health is recalling ChemoPlus protective gowns (251,165 units) distributed nationwide and in Canada due to incorrect expiration dating on packaging. The gowns have a three-year shelf-life but are mislabeled as five years.
Orthofix U.S. LLC is recalling 14,201 units of the Forza Ti Spacer System, a spinal fusion device, due to labeling inconsistencies where claims are not consistently present across affected units.
Orthofix U.S. LLC is recalling the FORZA PTC Spacer System due to labeling that contains claims not consistently presented across product materials. The recall affects multiple device models.
Fresenius Kabi is recalling specific lots of IVENIX INFUSION SYSTEM LVP Primary Administration Sets due to incorrect assembly that could result in serious patient injury. The recall affects 483 cases distributed nationwide.
Neurotransmitters Plus was distributed nationwide without FDA premarket approval or clearance. Patients should consult their healthcare provider regarding this device.
Food Intolerance Test Small by GET TESTED INTERNATIONAL AB was distributed nationwide without required FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling Allergy Test IgE devices distributed nationwide without FDA premarket approval or clearance. The devices were not validated before market distribution.
GET TESTED INTERNATIONAL AB is recalling Vitamin D-Test devices distributed without FDA premarket approval or clearance. The unapproved medical devices have not undergone FDA safety and efficacy review.
Philips is recalling IntelliVue Patient Monitor MX800 devices worldwide due to a potential issue where monitors may fail to alarm.
GET TESTED INTERNATIONAL AB is recalling GI Microbiome Profile XL for distribution without FDA premarket approval or clearance. All lots were distributed nationwide in the United States.
GET TESTED INTERNATIONAL AB is recalling all lots of its Mycoplasma IgG and IgM test kit due to distribution without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling the Diabetes HbA1c Test (all lots) due to distribution without FDA premarket approval or clearance. Approximately 148 units were distributed nationwide.
GET TESTED INTERNATIONAL AB is recalling the Candida Test due to distribution without FDA premarket approval or clearance. All 166 units distributed nationwide are affected.
GET TESTED INTERNATIONAL AB has recalled Food Allergy Panel Test kits distributed nationwide because they were marketed without FDA premarket clearance. Consumers should stop using the test and consult their healthcare provider.
GET TESTED INTERNATIONAL AB recalled its Kidney Test due to nationwide distribution without required FDA premarket approval or clearance. The device's safety and effectiveness were not established before distribution.
GET TESTED INTERNATIONAL AB is recalling its Blood Type Test due to distribution without FDA premarket approval. Consumers who have purchased this product should not use it.
GET TESTED INTERNATIONAL AB is recalling its Biological Age & Longevity Test due to distribution without FDA premarket approval. This unapproved diagnostic was distributed nationwide.
Philips is recalling IntelliVue MP5 patient monitors that may fail to alarm during patient monitoring. Failure to generate alerts could result in delayed detection of critical patient conditions.
Philips is recalling 1.9 million IntelliVue MP20 patient monitors (Product Number M8001A) worldwide because they may fail to alarm. All serial numbers are affected.
Philips IntelliVue Patient Monitor MX600 units may fail to sound alarms. Approximately 1.9 million units distributed worldwide; customers should contact Philips.
Get Tested International AB is recalling the Gut Microbiome Test Large because it was distributed without FDA premarket approval or clearance required by law.
The FDA is recalling a gonorrhea test that was distributed without required premarket approval and clearance. GET TESTED INTERNATIONAL AB must immediately cease distribution.
GET TESTED INTERNATIONAL AB recalled its Thyroid TSH Test (1916 units, US nationwide) because it was distributed without FDA premarket approval or clearance required for this Class II medical device.
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