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.
Philips North America is recalling 6 units of the Upgrade to MR 7700 because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 1 unit of the Evolution Upgrade 3.0T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 21 units of the Ingenia Ambition X because exported MR Elastography stiffness maps may show stiffness value errors.
LSL Healthcare is recalling 1,400 Central Line Dressing Kits because the BD ChloraPrep Triple Swabsticks inside exhibit an open seal on the applicator packaging.
Philips North America is recalling 10 units of the Ingenia 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 9 units of the MR 7700 MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 3 units of the Evolution Upgrade 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Aju Pharm is recalling 2,569 AlternatiV+ Max Knotless Anchors after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Philips North America is recalling 31 units of the Ingenia Elition X MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 200 units of the Genesis Push-In Suture Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Siemens is recalling 41 units of the LUMINOS Q.namix R fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.
Philips North America is recalling 1 unit of the Ingenia Ambition S because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 400 units of the Genesis Dual Thread Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Gold Star Distribution is recalling first aid kits and bandages over potential exposure of rodents and rodent activity in its distribution center.
Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.
Aju Pharm is recalling 416 units of the AlternatiV+ Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Gold Star Distribution is recalling feminine hygiene products over potential exposure of rodents and rodent activity in its distribution center.
Aju Pharm is recalling 1,163 units of the Genesis Knotless Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Gold Star Distribution is recalling pregnancy tests over potential exposure of rodents and rodent activity in its distribution center.
Philips North America is recalling 6 units of the Ingenia 3.0T CX MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 1,088 units of the Fixone Biocomposite Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Philips North America is recalling 3 units of the SmartPath to dStream for XR and 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 5 units of the Ingenia Elition S because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 600 units of the Genesis Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
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