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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.
Cardinal Health 200, LLC is recalling Monoject Blunt Cannula 22 G x 1-1/2" (Item code: 8881202389) because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Siemens is recalling 89 Artis zee multi units because a power supply issue may cause the X-ray generator to fail during procedures.
Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Randox Laboratories is recalling RX Daytona instruments due to a sensor malfunction that caused internal wire melting and scorch damage.
Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.
Siemens is recalling 32 AXIOM Artis dMP units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Siemens Medical Solutions is recalling 428 Artis zee ceiling units due to a power supply tolerance issue that may cause generator failure and prevent X-ray production.
Siemens is recalling 178 AXIOM Artis dTA units due to a power supply issue that may prevent X-ray generation during procedures.
Siemens Medical Solutions is recalling 170 Artis zee floor units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens is recalling 268 Artis zee biplanes because a power supply tolerance issue may cause generator failure, preventing X-ray production during procedures.
Abbott Laboratories is recalling 11,063 Immunoglobulin G in vitro diagnostic kits to update instructions for use regarding reagents and specimen handling.
Getinge US Sales LLC is recalling seven PulsioFlex Monitoring Systems because they display an internal error message requiring restart or service.
Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.
Siemens is recalling 24 AXIOM Artis MP units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Terumo Medical Corporation is recalling 638,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.
Becton Dickinson is recalling 3mL Luer-Lok syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.
Siemens is recalling five AXIOM Artis FC units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Siemens Medical Solutions is recalling 117 Artis zeego units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.
Siemens is recalling 23 Artis zee floor MN units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Abbott Laboratories is recalling 2,273 Apolipoprotein B in vitro diagnostic kits because the Instructions for Use (IFU) required updates to reagent and specimen handling sections.
Becton Dickinson is recalling 428,800 3mL Safety-Lok Syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.
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