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.
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.
Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Medline is recalling 15 CV Anesthesia Room Setup kits because a packaging defect may allow non-sterile product use if the pouch seal is opened.
Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.
Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Baxter Healthcare is recalling 542 units of the Operating Table TruSystem 7000 U14 worldwide due to reports of electrical short-circuits and smoke emissions from batteries and connectors.
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
Smiths Medical is recalling approximately 3,280 medex TranStar KIDS KIT blood sample devices due to a manufacturing defect causing pressure monitoring failures.
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.
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