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.
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.
Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.
SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.
Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.
Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.
Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.
Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.
Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.
Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.
Looking for a different category? Browse all recalls.