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.
Tenderneeds Fertility LLC is recalling the Pro Series Fertility Device because it was distributed without proper marketing authorization.
Gf Health Products is recalling 66 units of the Drop Arm Versamode because the front casters are incorrect. The devices were distributed in the US and internationally.
Tenderneeds Fertility LLC is recalling its Premium At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Nuvasive Specialized Orthopedics is recalling PRECICE limb lengthening devices because they lack full biological assessments and are not indicated for patients under 18.
Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.
Heartware is recalling Medtronic HVAD Packaged Monitors because worn cables may damage controller ports during insertion.
Integra LifeSciences is recalling 49 units of CODMAN HAKIM BACTISEAL Shunt System catheters because they lacked required drainage holes and markings.
Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.
Nuvasive Specialized Orthopedics Inc. is recalling 59 units of Freedom End Caps and related components because they lack full biological assessments and are not indicated for patients under 18.
Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables because they may damage HVAD Controller ports due to wear from misalignment.
Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.
Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.
Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.
Clerio Vision is recalling 153 Extreme H2O 59% contact lenses because they may be mislabeled with the incorrect lens power.
Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.
Nuvasive Specialized Orthopedics is recalling Precice Unyte orthopedic trauma nails because they lack full biological assessments and are not indicated for patients under 18.
FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.
The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.
Medtronic is recalling Bio-Console 560 devices because an electrical component may fail, causing the pump to stop and potentially producing smoke or a burning odor.
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.
Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.
Looking for a different category? Browse all recalls.