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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.
Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.
Medline is recalling 7,913 reprocessed ViewFlex Xtra ICE catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 498 MAGNETOM Vida (DE) MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 39 MAGNETOM Skyra Fit BioMatrix systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Medline is recalling 7,913 reprocessed Livewire Steerable Electrophysiology Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
Siemens is recalling 41 MAGNETOM Vida Fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.
Zap Surgical Systems is recalling 17 ZAP-X Radiosurgery Systems because a software defect could let the collimator collide with a patient's shoulders or the patient table.
S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.
Change Healthcare is recalling 12 programs running Radiology Solutions software version 14.2.2 because a software issue means radiology reports may not be fully displayed.
North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.
Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.
Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Medtronic is recalling 1,440 Simplera Sensors because the device cap label may not adhere to the sensor, compromising sterility and increasing the risk of infection.
Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
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