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.
Siemens is recalling 148 AXIOM Artis dFC units because a power supply defect may cause the X-ray generator to fail during procedures.
Abbott Laboratories is recalling 9,586 Immunoglobulin M diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Abbott Laboratories is recalling 22,359 Transferrin in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Abbott Laboratories is recalling 2,112 Apolipoprotein A1 assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Epimed International is recalling 200 Versa-Kath Mini Kits because the labeling incorrectly states a 12-gauge catheter is included, while the kit actually contains a 21-gauge catheter.
Terumo Medical Corporation is recalling 440,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.
Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Siemens is recalling 39 AXIOM Artis dFA units because a power supply issue may cause generator failure, preventing X-ray production during procedures.
Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity that may compromise sterility.
Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation during procedures.
Siemens Medical Solutions is recalling three Artis zee biplane MN units due to a power supply tolerance issue that may prevent X-ray generation during procedures.
Siemens is recalling four AXIOM Artis FA units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
CellEra LLC is recalling 2,110 units of VITALE Silicon Foam Dressings because the adhesive border was not sticky enough.
Siemens is recalling seven AXIOM Artis BA X-ray systems because a power supply defect may cause the generator to fail, preventing X-ray imaging.
Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.
Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.
Medela Inc is recalling 665,600 breast milk transfer lids because packaging breaches may compromise sterility, even if the packaging appears intact.
Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.
Siemens is recalling five AXIOM Artis TA units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Siemens is recalling six AXIOM Artis BC units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Siemens is recalling 53 AXIOM Artis dBC units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Siemens is recalling 98 AXIOM Artis dTC units because a power supply tolerance issue may cause generator failure, preventing X-ray imaging.
Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.
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