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.
AMD Medicom Inc. is recalling Level 2 masks that may have been packed in Level 3 boxes, creating a risk of using lower-protection masks.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units distributed worldwide.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
Cook Inc. is recalling 585 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise the sterility of the devices.
Cook Inc. is recalling 80 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide and across the US.
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
Cook Inc. is recalling 85 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Cook Inc. is recalling 98 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and in the US.
Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.
Cook Inc. is recalling 25 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The products were distributed worldwide.
Cook Inc. is recalling 1,125 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
Becton Dickinson is recalling BD Posiflush syringes because a limited number of experimental units were mixed with standard products.
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.
Auris Health is recalling 158 Monarch Aspirating Biopsy Needles because of reports of needle breakage. The devices were distributed to 11 states.
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