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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 Industries is recalling Unna-Z compression wraps due to contamination with common mold species. The recall affects units distributed in the US and several international countries.
Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.
Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.
Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.
Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.
Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.
Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.
Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.
Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.
Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.
Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield falsely low results for samples with extremely high IgG4 levels.
Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.
Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.
Philips Medical Systems is recalling a Brilliance iCT unit in Australia because a rotor counterweight bolt may have been improperly torqued.
The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.
Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.
Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.
PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.
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