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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.
Cardinal Health is recalling approximately 24,963 Jackson-Pratt Channel Drains due to multiple performance defects including broken tips, dull insertion tools, reduced flexibility, and visibility issues. Units were distributed worldwide.
Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.
Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units distributed worldwide.
Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.
Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The recall affects 7,129 units distributed worldwide.
Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.
Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.
Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.
Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.
Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.
Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.
Cardinal Health is recalling Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. About 1,768 units were distributed worldwide.
Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.
Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.
Cardinal Health is recalling 3,507 Jackson-Pratt Channel Drains (19 Fr) due to performance defects including lack of radiopacity, dull trocars, lack of flexibility, and broken tips. Drains were distributed worldwide.
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.
Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.
Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2230) are recalled due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting 29,515 units.
Cardinal Health is recalling Jackson-Pratt Channel Drains (10 Fr, REF JP-2221) due to multiple performance issues including broken wound tips, dull trocars, lack of radiopacity, and reduced flexibility affecting 179 units distributed worldwide.
Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.
Cardinal Health is recalling Jackson-Pratt Channel Drains (7mm, REF JP-2210) for performance issues including lack of radiopacity, dull trocars, poor flexibility, and broken tips. Affected units may not function properly.
Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.
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