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.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.
Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.
Visicu, Inc. is recalling 43 units of eCareManager software due to a defect that may cause incorrect medication orders to be displayed and signed.
LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.
Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.
In2Bones is recalling 20 units of Model S25 ST014 osteosynthesis screws distributed in Tennessee because they were manufactured with the incorrect Torx imprint on the screw head.
LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
BioHorizons is recalling 32 units of 5.0 x 15mm dental implants because the packaging incorrectly listed the length as 10.5mm.
LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.
Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.
Valeant Pharmaceuticals is recalling 61 units of the SPAG-2 6000 aerosol generator because they were released without required particle size testing.
Powers Medical Devices is recalling 128 Pacifier Activated Lullaby (PAL) Systems because the units' labeling is inconsistent with their FDA-cleared indications.
Smith & Nephew is recalling 9 units of PERI-LOC Volar Distal Radius Plates that were laser marked and packaged with incorrect anatomical orientation.
Smith & Nephew is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATES because they were laser marked and packaged with incorrect anatomical orientation.
Windstone Medical Packaging is recalling 40 kits of the AMS 4674 Custom Pack because they contain a recalled Seldinger Needle component.
Windstone Medical Packaging is recalling 40 kits of the AMS 4675 Angio Pack because they contain a recalled Seldinger Needle.
LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.
LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.
LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.
Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.
Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.
Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.
Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.
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