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.
Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary recall of VY Flush Heparin Lock Flush Syringes.
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Plasma Surgical Inc. is recalling 36 PlasmaJet Open Surgery Handpieces because a potential seal failure may cause a small drop of distilled water coolant to leak during use.
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers products distributed nationwide.
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The syringes are used to maintain the patency of indwelling catheter lumens.
Vygon is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits nationwide.
Vygon Corporation is recalling Heparin Lock Flush Syringes and kits due to a voluntary recall of related VY Flush Heparin Lock Flush Syringes.
Vygon is recalling Heparin Lock Flush Syringes and kits containing them due to a voluntary recall of similar syringes by the manufacturer.
Vygon is recalling heparin lock flush syringes and kits due to a manufacturer recall of VY Flush Heparin Lock Flush Syringes.
Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.
Integra LifeSciences Corp. is recalling 42 units of Mozaik Putty because the Instructions for Use contain incorrect Spanish and French translations of the term 'bone marrow aspirate'.
Integra LifeSciences Corp. is recalling Integra Mozaik Strip units because the Instructions for Use contain incorrect Spanish and French translations of the term "bone marrow aspirate."
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