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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.
C.R. Bard is recalling 17,250 Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate or reduced suction, decompression, and drainage during use. These tubes may not function properly for their intended medical purpose.
Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.
Beckman Coulter recalled the REV 2 Flowcell Capsule Spare due to potential rust in the cannula component, which could generate erroneous test results.
C.R. Bard is recalling 133,610 Bard Suction Connectors with ENFit (model EN0066000) due to user complaints of inadequate suction and drainage. No injuries have been reported.
C.R. Bard is recalling 3,360 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use.
C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
Turkuaz Saglik Hizmetleri is recalling over 4.9 million units of sterile ultrasound gel (REF 126590) because manufacturer cannot guarantee its sterility. Affected products in Illinois and Hong Kong should not be used.
Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.
The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.
Cooling cabinets in Philips MRI systems have defective electrical warning labels with incorrect colors and a missing high voltage warning symbol, creating electrical shock risk for service personnel.
Philips MRI systems have an incorrect electrical shock warning label missing high-voltage symbols, risking shock to service personnel.
Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.
Some Philips Intera 1.5T MRI systems have an incorrect warning label on the Liquid Cooling Cabinet that fails to properly warn service personnel of electrical shock hazards.
Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.
Philips Achieva 3.0T MRI systems have an incorrect electrical warning label on the liquid cooling cabinet, missing the high voltage symbol and proper yellow background. This presents a risk of electrical shock to service personnel.
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.
Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.
Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
Oakworks recalled 20 Ultrasound EA and G3 examination tables due to backrest platform stress fractures that prevent proper operation in inclined positions. Affected units are identified by serial number.
Smiths Medical is recalling 31,685 units of pressure tubing with defective O-rings that may not seal properly during medication infusion, potentially causing medication leaks and underdosing. The defect affects specific lot numbers with worldwide distribution.
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