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.
GE MAC 5 A4 and A5 Resting ECG Analysis Systems are being recalled because a development software version was released that can associate clinical information with the wrong patient.
ARTIS Icono interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.
Sharpoint 2.2 mm angled double-bevel microsurgical knives are being recalled because 3.0 mm knives were labeled and packaged as 2.2 mm. 1,818 units affected.
Philips Azurion 7B12/12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
ARTIS pheno interventional fluoroscopic X-ray systems are being recalled because they may sporadically display a zero X-ray dose even though an actual dose is applied to the patient.
Titanium/fluoroplastic piston stapes prostheses are being recalled because the device labeling states an incorrect functional length. Seven units are affected.
Philips Azurion 3M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
The Large Volume Pump of the Ivenix Infusion System is being recalled because of the potential for the Cassette Loading Lever to break. 18,444 installed bases are affected.
Arvis Hip & Knee 2.0 Instrument Sets are being recalled because the Impactor V-Block Assembly and Trackers may show early wear or corrosion on the exposed magnet face.
The Da Vinci 5 system tower is being corrected because the near infrared handheld camera can be unintentionally activated when a user tries to turn off illumination.
CASE v7.0 Cardiac Testing Systems are being recalled because electrical sparking may occur at the printer head, and ignition of thermal paper could cause serious thermal injury.
The BD Pyxis MedBank Tower medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
The BD Pyxis MedStation 4000 medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
Avanta Multi-Patient Administration Tube Sets are being recalled because supplier changes created a fit issue, so the stopcock cannot be reliably engaged with the Contrast Flow Control Valve.
BD Pyxis Mini Main medication cabinets are being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn. 709 units affected.
Phothera 200 phototherapy devices are being recalled because some Calibration and Output Certificates had the outputs reversed. 368 units are affected.
Arvis Hip & Knee 3.0 Instrument Sets are being recalled because the V-Block Assembly and Trackers A, B, C and E may show early wear or corrosion on the exposed magnet face.
Philips Azurion 7M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
B. Braun Lyndon B Johnson Hospital spinal epidural kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
B. Braun CESK Harris Methodist kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 units are affected.
DeRoyal Industries Inc. is recalling Covaderm Plus Vascular Access Dressings because they lack sterility assurance.
HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are being recalled due to an incorrect shelf-life expiration date. 36 units are affected.
Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.
Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.
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