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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.
Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.
Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.
Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.
Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.
Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.
Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.
A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.
Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering system shutdown.
The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.
Siemens Medical Solutions is recalling 20 Artis pheno diagnostic imaging systems nationwide due to software errors in block movement and detector rotation functions. The malfunction may limit device functionality and delay clinical treatment until the system restarts.
Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.
Huntleigh Healthcare Ltd. is recalling 150 HUNTLEIGH Disposable Intraoperative Probes (8MHz) because the faceplate may become detached from the probe body during use.
Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.
The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.
Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.
Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.
Qiagen Sciences LLC is recalling the therascreen KRAS RGQ PCR Kit due to potential false positive or false negative results in KRAS G12C mutation detection. These inaccurate results could invalidate clinical test outcomes.
GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.
Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.
Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.
Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.
St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.
Sartorius Corporation is recalling the Virus Counter Platform Model VC3100 (model numbers VIR-92166, VIR-92341) distributed nationwide to 82 units, classified as a Class II FDA medical device recall.
Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees in Missouri.
Siemens is recalling 305 Artis zee floor X-ray imaging systems because the cooling circuit may fail to maintain adequate coolant levels, potentially causing the X-ray tube to overheat. The system includes automatic safeguards that shut down X-ray operation if overheating is detected.
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