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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.
Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.
Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient data to support the labeled 10-year shelf life.
Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.
Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution due to potential failure in stability antimicrobial effectiveness testing.
Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failure in antimicrobial effectiveness testing.
Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.
Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.
Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution due to potential failure in antimicrobial effectiveness testing.
Cardiocommand Inc. is recalling six TAPSYSTEM Model 2A units due to a potential assembly error where the battery wire may be incorrectly connected to the power switch.
Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.
Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.
Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.
GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them instead of the designated handles.
Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.
Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.
GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.
Siemens is recalling one Cios Alpha VA20/VA30 mobile X-ray system because the DAP chamber may be missing an insulating foil.
Applied Medical Resources Corp is recalling Kii Fios First Entry devices because they may not have met sterility requirements, potentially exposing patients to infectious agents.
Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.
Siemens Medical Solutions is recalling one Cios Care Fusion System unit because the DAP chamber may be missing an insulating foil.
COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.
Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.
Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.
Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.
Rinovum Women's Health is recalling the Revive Reusable Bladder Support because the device may split or crack during its intended use life.
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