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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.
Cooling cabinets in Philips MRI systems have defective electrical warning labels with incorrect colors and a missing high voltage warning symbol, creating electrical shock risk for service personnel.
Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.
Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.
Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.
Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.
Abbott is recalling FreeStyle Libre 3 App on Android 13 devices due to signal loss that may prevent users from receiving glucose readings and alarms, potentially delaying necessary treatment.
Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.
Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.
Getinge USA is recalling Maquet Orchide OR Light Systems due to a potential for light fixtures to fall in the operating room. No injuries have been reported.
Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.
Xcision Medical Systems recalled 4 GammaPod Treatment Planning Systems due to a software error that allows incorrect radiation structures from previous CT scans to be imported and selected, potentially affecting treatment planning accuracy.
Smiths Medical Asd Inc is recalling approximately 31,685 Stopcock Left Rotator devices due to oversized O-rings that may compromise seal integrity. The defect may cause medication leaks, potentially resulting in under-infusion during treatment.
Cardinal Health suction canister liners may lose suction on low settings due to liner misalignment. Approximately 203,244 units distributed to the US, Canada, Australia, and New Zealand.
Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.
Getinge recalls 236,793 units of Maquet PowerLED and PowerLED300 operating room light systems due to a potential for the light to fall in the operating room.
Sarnova HC is recalling the Curaplex Field Cric Kit due to an incompatible endotracheal tube holder that prevents practitioners from securing the tube during cricothyrotomy procedures. The recall affects 1,063 kits distributed nationwide.
Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.
Oakworks Inc is recalling 28 Ultrasound EA examination tables due to backrest platform stress fractures that prevent operation in an inclined position.
Philips Patient Information Center iX devices may fail to send push notifications under certain conditions, potentially delaying detection of patient condition changes. A total of 814 units have been recalled worldwide.
Smiths Medical is recalling 31,685 HIGH PRESSURE ROTATOR infusion devices with a manufacturing defect that may cause an inadequate seal. The defect could lead to medication leaks and under-infusion.
Smiths Medical is recalling High Pressure Rotators due to a manufacturing defect affecting O-ring seals. An oversized inner diameter may cause inadequate seal integrity, risking medication under-infusion.
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