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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.
JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do not perform according to specifications.
Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.
Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Custom MDA Tubes because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Nose Cone Covers because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling three XMax Motor units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 40 units of 3mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom extension bearing sleeves because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of the 2.37mm Spiral Drill because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom Sagittal microSaw Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling eMax2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools because they were not manufactured consistently with Quality System requirements.
Integra LifeSciences is recalling 61 units of Accell Evo3C Demineralized Bone Matrix because they were incorrectly packaged in boxes for a different product, creating a risk of improper surgical use.
Teleflex Medical is recalling RUSCH LaserTube tracheal tubes because the label failed to print a specific caution statement regarding natural rubber latex.
The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling four Custom Medium Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling custom shoulder implants because they were not manufactured consistently with Quality System requirements.
Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
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