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.
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 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 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.
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.
Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.
Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.
Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains due to multiple performance issues: lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
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.
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.
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 due to performance defects: dull trocars, broken tips, lack of flexibility, and radiopacity issues. The 8,563 affected units were distributed worldwide.
Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.
Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2225) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 4,112 units were distributed worldwide.
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.
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.
Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.
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.
R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.
Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.
Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.
Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
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