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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 MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Hiossen is recalling 119 Osstem dental implant abutments because patient chart stickers incorrectly identify product versions. ET Rigid and ET Multi abutments are labeled backwards, potentially leading to selection of the wrong abutment size.
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to seizure, coma, or death.
Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.
DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.
Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.
Murata Vios bedside monitors may experience battery depletion if stored without power, causing tablet connectivity issues. Affected units should be kept plugged in while in storage.
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.
Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.
Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.
Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.
Hiossen Inc. is recalling ET Rigid Abutments due to incorrect patient chart stickers that misidentify product versions. The stickers may label Mini abutments as Regular or identify other abutment models incorrectly, risking use of the wrong component.
Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.
HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the water jet may emerge as a spot jet rather than the specified fan-shaped spray pattern, affecting device functionality.
Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.
Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.
Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.
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