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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.
Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.
Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.
Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.
Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative results.
Ventana Medical Systems is recalling 342 units of the ultraView SISH DNP Detection Kit because leaking dispensers may cause false negative IHC results.
Degania Silicone is recalling 153 temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Coviden is recalling temperature sensing Foley catheters that may display lower body temperature measurements than the patient's actual temperature.
Degania Silicone is recalling 89,122 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
ShinChang Medical Co., Ltd. is recalling 6,570,800 disposable insulin syringes because a small crack was found in the top end of the barrel near the needle.
EOS Imaging is recalling 17 sterEOS workstations because 3D projections may be incorrect when using specific secondary image captures, potentially leading to clinical errors.
Degania Silicone is recalling 4,332 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
bioMerieux is recalling VITEK 2 AST-P655 cards because six lots were manufactured with insufficient gentamicin, potentially affecting high-level resistance screening results.
Degania Silicone is recalling 330 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 500 units of temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.
Permobil is recalling 3,134 powered wheelchairs because backrest support bars may fail, potentially causing users to fall backward and sustain injuries.
Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual.
Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.
Degania Silicone is recalling 2,461 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.
Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Medline Industries is recalling single-use endoscopic cleaning brushes because they may detach during cleaning, potentially leaving parts inside the scope.
Degania Silicone is recalling 34,627 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures 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.
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