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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.
Draeger Medical is recalling Set2Go Ventilation 12 devices due to defective glued connections in the breathing circuit that can loosen or detach during ventilation.
Draeger Medical is recalling the Seattle PAP Plus due to glued breathing circuit connections that may loosen or completely detach during ventilation, potentially interrupting airflow.
Glued connections on the VentStar Watertrap breathing circuit can become loose or detach during ventilation, potentially interrupting airflow. Draeger Medical is recalling all affected units nationwide.
Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.
Draeger Medical recalls VentStar Watertrap (P) 180 breathing circuit equipment because glued connections can become loose or detach before or during ventilation.
Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.
Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.
Draeger Medical recalls 2,380 Ventstar Coax breathing circuits due to glued connections that can become loose or detach during ventilation.
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
Draeger Medical recalls ID Coax 180 breathing circuit components due to glued connections that can become loose or detach during ventilation.
Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.
The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.
Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.
Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.
Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.
Fisher Wallace Stimulator Models FW-100 and FW-200 are being recalled because incorrectly installed batteries may cause the device to overheat, potentially resulting in burns. The recall affects 43,489 devices distributed nationwide and globally.
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.
Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.
Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.
240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.
The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.
Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.
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