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.
GET TESTED INTERNATIONAL AB is recalling Peptic Ulcer Test (H. pylori) due to distribution without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider.
GET TESTED INTERNATIONAL AB is recalling Gut Microbiome Test XL nationwide because the device was distributed without FDA premarket approval or clearance. Consumers should discontinue use and contact the manufacturer.
GET TESTED INTERNATIONAL AB is recalling the Food Intolerance Test Large (EAN: 616612785640) that was distributed nationwide without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling its Serotonin Test distributed nationwide because the device was marketed without required FDA premarket approval or clearance. Stop using the product and contact the manufacturer for return instructions.
Food Sensitivity Test Medium manufactured by GET TESTED INTERNATIONAL AB has been recalled due to distribution without FDA premarket approval. Consumers should stop using and dispose of the product.
GET TESTED INTERNATIONAL AB is recalling the Female Fertility Test nationwide. The product was distributed without FDA premarket approval or clearance, which is required for medical devices.
GET TESTED INTERNATIONAL AB is recalling its Pet Allergy Test product (EAN: 616612785695) distributed in the U.S. without FDA premarket approval or clearance. Approximately 29 units distributed nationwide are subject to this Class II recall.
GET TESTED INTERNATIONAL AB is recalling its HPV Antigen Test (258 units, all lots) nationwide due to distribution without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling Hair Mineral Analysis kits distributed nationwide without FDA premarket approval. Consumers should stop using this product.
GET TESTED INTERNATIONAL AB is recalling the NAD Profile Test (all lots) because it was distributed without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling an Iron Deficiency Test (ferritin) that was distributed without FDA premarket approval. All lots should not be used.
GET TESTED INTERNATIONAL AB is recalling 754 units of its 2 in 1 Trichomonas / Gardnerella Test that was distributed nationwide without FDA premarket approval or clearance. The recall affects all lots.
Olympus is updating reprocessing materials and instructions for the TJF-Q190V duodenovideoscope (7,023 units nationwide) following continued reports of infections. Users must follow updated reprocessing instructions closely.
Glycar SA recalls SJM Pericardial Patches (Model C0914) that may not meet required tensile strength specifications. 30 units were distributed in the US.
Glycar SA is recalling 18 units of SJM Pericardial Patch (Model C0510, lot T2506245) because the devices may not meet required tensile strength specifications. Affected patients and healthcare providers should consult regarding device performance.
Olympus is recalling the HX-400U-30 ligating device used in endoscopy procedures because the nylon loop may fail to release properly from patient anatomy. The recall affects 7,803 units distributed throughout the United States.
B Braun Medical Inc recalls IV Administration Sets due to potential medication backflow from secondary into primary containers and priming failure. Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore.
B Braun Medical Inc is recalling 63,192 IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime the sets.
B Braun Medical Inc recalls IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime.
B Braun Medical is recalling 4,536 IV Administration Sets worldwide due to potential backflow of medication from secondary containers into primary containers and inability to prime. This could compromise safe medication delivery.
B Braun Medical is recalling IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The defect may result in wrong medication delivery or medication delivery failure.
B Braun Medical recalls SAFELINE IV administration sets due to potential medication backflow from secondary containers and inability to prime, affecting 46,250 units distributed worldwide.
Mindray's Isoflurane V90 Electronic Vaporizer with A9 Anesthesia System is being recalled due to potential anesthesia leakage. The recall affects 54 units distributed across multiple US states and Canada.
B Braun Medical is recalling 32,436 Anesthesia IV Sets used with multiple infusion pumps due to potential backflow of medication from secondary containers and inability to prime. No illnesses or injuries have been reported.
B Braun Medical Inc is recalling IV administration set components that may allow medication to flow backward from secondary containers or prevent proper priming. The recall affects approximately 381,850 units distributed worldwide.
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