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.
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.
Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.
Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.
C.R. Bard Inc is recalling Silastic Brand Foley Catheters because of stain present on the surface of affected units. The recall affects 106,160 catheters distributed across the United States and Canada.
Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.
On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.
Medline is recalling the Namic Preceptor Manifold due to particulate matter found in the fluid path. The recall affects 760 units distributed in the US and eight other countries.
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.
Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.
Medline Industries is recalling medical convenience kits (HEART CATH PACK-LF, Kit Number DYNJ36478B) due to particulate matter found in the fluid path of the Namic Manifold. Affected kits were distributed in the US and internationally.
Medline Industries is recalling cardiac medical convenience kits containing Namic Manifolds due to the presence of particulate matter within the fluid path. The affected kits were distributed nationwide and internationally.
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.
Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.
Windstone Medical Packaging is recalling Custom Convenience Kits containing Medline Namic Angiographic Control Syringes due to risk that the rotating adapter may unwind during use, potentially causing disconnection and exposure to biohazards, blood loss, infection, or air embolism.
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.
Medline is recalling 107 medical convenience kits containing Namic Manifold (TAVI) due to particulate found in the fluid path. The kits were distributed nationwide and internationally.
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.
Medline Industries is recalling Namic Preceptor Manifold extravascular blood pressure transducers due to the presence of particulate matter within the fluid path. The recall affects 6,390 units distributed nationwide in the US and internationally.
Medline Industries is recalling approximately 7,075 units of the Namic Angiographic Manifold (SKU 64038200) due to particulate found in the fluid path. The manifold is used in cardiopulmonary bypass procedures and is distributed across the US and internationally.
Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.
Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
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