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.
Abbott Molecular is recalling 176 m2000sp automated sample preparation systems because the x-drive assembly may fail prematurely, potentially causing the manipulator arm to contact objects or pipet improperly.
Sun Nuclear Corporation is recalling six IC Profiler-MR Model 1123 units due to a potential pinch hazard to users performing quality assurance in MRI environments.
Siemens Medical Solutions is recalling seven SOMATOM Force CT scanners because artifacts were found in acquired imaging.
Brainlab AG is recalling iPlan RT radiation treatment planning software due to a risk of incorrect patient positioning when using multiple localized CT image data sets.
Becton Dickinson is recalling specific lots of Trypticase Soy Agar and MacConkey II Agar plates due to low-level Listeria monocytogenes contamination.
Siemens is recalling 50 Artis Q and Artis Q.zen ceiling systems because suboptimal cable routing may cause wear, leading to limited functionality or system failure.
Intertrade Imports Inc. is recalling I Color Complete color contact lenses because FDA testing found Bacillus Cereus and Bacillus Lentus. The lenses are also unapproved medical devices.
SpineFrontier, Inc. is recalling four Inline Persuader PedFuse Pedicle Screw Systems because a crack may develop in the handle, potentially progressing with continued use.
St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because a software reset may cause backup operation in implanted cardiac devices.
Synthes, Inc. is recalling Malleable C-Retractors because the internal spring may corrode or fail, potentially transferring particles to patients and causing adverse tissue reactions or infection.
Invivo Corporation is recalling 20 Philips Expression MR200 MRI Patient Monitoring Systems due to capacitor shorts that may cause electrical shock or loss of monitoring.
Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.
Philips is recalling Brilliance and Ingenuity CT systems because improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
GE Healthcare is recalling 24 Discovery IGS 730 and 740 angiographic X-ray systems due to a user interface issue that may cause unintentional system motion or rotation.
Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.
Becton Dickinson & Co. is recalling Columbia Agar with 5% Sheep Blood due to low-level Listeria monocytogenes contamination. The product is a non-sterile culture medium distributed worldwide.
Becton Dickinson is recalling CDC Anaerobe 5% Sheep Blood Agar due to low-level Listeria monocytogenes contamination. The affected non-sterile media were distributed worldwide.
Siemens Medical Solutions is recalling 295 Symbia T and T2 CT systems because a component may come loose and damage the equipment.
Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.
Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.
Straumann USA is recalling dental implant drill sets that may contain incorrect drills. The recall covers 362 pieces distributed nationwide and internationally.
GE Healthcare is recalling 13 Revolution CT scanners to perform a required torque check on three bolted joints. No injuries or illnesses have been reported.
Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.
Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.
Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.
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