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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.
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.
Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.
Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.
Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.
A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.
Philips Panorama HFO MR diagnostic imaging systems (Model 781350) contain a loose terminal connection in the mains distribution unit that may create a hotspot and cause smoke or fire. Approximately 118 units are affected worldwide.
Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.
Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses have been reported.
Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.
GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.
Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.
Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.
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