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.
Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.
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.
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 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.
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.
Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.
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.
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.
Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
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.
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.
3M is recalling 3M Attest Steam Chemical Integrators manufactured November 2022–January 2023 due to increased potential for ink leakage during sterilization cycles. Approximately 16.2 million units were distributed worldwide.
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.
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.
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.
Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.
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.
The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.
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.
Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.
Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.
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.
Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.
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