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.
Gardner Denver Thomas Inc is recalling 370 units of the MEDI-PUMP Aspirator, Model 1242, because the vacuum pump may not perform to specification.
CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.
Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.
Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling Sureflex 273 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.
Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.
Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.
Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.
Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.
ViewRay is recalling three units of Patient Handling System software due to a report of the couch moving unexpectedly into the bore after a reboot.
Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.
Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.
Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.
Sorin Group USA is recalling 21 Sorin Stockert Heater-Cooler 3T units due to the potential for organism colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.
Sorin Group USA is recalling 131 Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.
Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.
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