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.
Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.
Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.
Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.
Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Stanley Healthcare is recalling 137 Arial 54315 Network Managers because they caused outages in the Arial nurse call system.
Terumo Medical Corporation is recalling 810,000 18G needles due to a potential loss of package integrity that may compromise sterility.
Philips Medical Systems is recalling 696 BrightView SPECT units because the handcontroller may move spontaneously or continue moving after buttons are released.
Siemens is recalling 85 AXIOM Artis dBA units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Cardinal Health 200, LLC is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.
CooperSurgical is recalling LEEP Precision Integrated Systems because the foot pedal may fail to operate the cut, coagulate, or blend functions.
Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the sterility barrier.
Cardinal Health is recalling specific lots of Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.
Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.
Cardinal Health 200, LLC is recalling Monoject Blunt Cannula, 20 G x 1-1/2" (Item code: 8881202363), because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Zevex Incorporated is recalling specific lots of MOOG Curlin Infusion Administration Sets because they leaked at the filter.
Terumo Medical Corporation is recalling 444,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Terumo Medical Corporation is recalling 30,000 units of 23G x 1-inch needles (Lot 180811C) because a potential loss of package integrity may compromise the product's sterility.
Laborie Medical Technologies is recalling two U3-3 Solar Blue power supply units due to incorrect labeling and insulation material that does not meet flammability requirements, posing a potential fire hazard.
Cardinal Health 200, LLC is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.
Cardinal Health is recalling Monoject Standard Hypodermic Needles due to a manufacturing defect that could compromise the sterility barrier.
Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
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