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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.
Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.
Medtronic Navigation is recalling 63 O-arm 02 surgical x-ray imaging systems nationwide due to gaps in electronic product labeling and Instructions for Use compliance.
ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.
Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 because incorrect calibration mathematics may cause biased test results for total iron-binding capacity.
Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).
Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.
Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.
CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.
Elekta is recalling 69 MOSAIQ Oncology Information System units because scrolling the mouse wheel could accidentally change the selected treatment plan.
Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.
Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.
Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.
Medical Depot Inc. is recalling 123,125 pairs of Universal Quick Adjust aluminum crutches because the metal tips may fail and detach from the ground.
Pentax Medical is recalling 17 Confocal GI Scopes because operational and therapeutic accessories can become lodged in the instrument channel.
Medtronic is recalling 368 Sagittal Saw devices because testing identified a potential for fluid leakage into the motor during use.
Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Hospira is recalling approximately 3.9 million LifeShield IV administration sets because fluid may leak at the secondary port.
Pentax Medical is recalling 4,195 bronchoscopes because operational and cleaning accessories can become lodged in the instrument channel.
Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.
Beckman Coulter is recalling Access Free T3 Assay kits because they may show an upward shift in patient results. The recall covers 205,744 kits distributed worldwide.
Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.
Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.
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