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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.
Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.
Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.
Degania Silicone is recalling 16,133 temperature sensor catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling Foley catheters with temperature sensors because defective units may display lower body temperatures than actual.
Covidien is recalling P400 temperature sensor catheters because they may display lower body temperature readings than the patient's actual temperature.
Coviden is recalling Temp Sense Silicone catheters because they may display lower body temperature measurements than the patient's actual temperature.
Medtronic is recalling two Contour Plus Link 2.4 meters distributed in Slovakia that display glucose in mg/dL instead of mmol/L.
Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.
Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.
Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.
Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.
Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.
Zimmer Biomet is recalling 52 Gentle Thread PLGA Full Thread Interference Screws because they were commingled with a different size.
bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.
Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.
Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.
Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.
Zimmer Biomet is recalling 52 Gentle Thread PLGA Round Head Interference Screws because they were commingled with a different screw size.
Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.
Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
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