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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.
FUJIFILM is recalling Noblus AC Adapters nationwide due to fire and smoke hazard. The adapters can overheat and generate smoke when the power cable is repeatedly inserted and removed.
Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.
Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.
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 has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke in hospital technical rooms.
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.
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.
MEDLINE has recalled 42,000 non-sterile syringes (Model 91847) because their sizes and configurations exceed FDA-approved specifications. The products were distributed nationwide.
A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.
Medline's non-sterile syringes (Model 91877) are recalled because their sizes and configurations exceed what was approved under the firm's 510(k) clearance. The regulatory non-compliance affects 3,840 units distributed nationwide.
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
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