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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.
Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.
Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.
Nurse Assist, LLC recalls sodium chloride irrigation solutions and IV flush syringes due to potential lack of sterility assurance, which could allow contamination and infections.
Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.
Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.
ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.
ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.
ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.
ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.
ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.
ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.
ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.
Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.
Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
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