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.
Stryker is recalling 59 M-1 Cot Fasteners distributed to the Netherlands because their operation and maintenance manuals are missing warnings and contain incorrect information.
Siemens Healthcare Diagnostics is recalling Atelia IM 1300 Analyzers because reporting and conversion factors may not apply to all units when connected to a single solution system.
Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips due to a potential loss of glucose analyte activity before the stated shelf life.
Beijing Syntech Laser Co., Ltd is recalling 92 UL C02 Laser surgical lasers because the required certification label was not affixed to the product.
Becton Dickinson is recalling BD MAX DNA MMK Lab Use because the package insert incorrectly lists the diluent volume, which could affect assay results.
Beijing Syntech Laser Co., Ltd is recalling 199 UL Station surgical lasers because the required laser safety certification label was not affixed to the product.
Beijing Syntech Laser Co., Ltd is recalling 38 Trixel C02 Laser surgical lasers because the required certification label was not affixed to the product.
Conseal International is recalling 384 units of Nanosil Spray Gel due to FDA inspection findings of manufacturing deficiencies and missing expiration dates.
DeRoyal Industries is recalling 1,800 non-sterile electrosurgical pencils that were incorrectly labeled as sterile. The affected units were distributed to Honduras, Belgium, and The Netherlands.
CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannulas because they were packaged with the wrong trocar length type.
Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.
Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.
Beijing Syntech Laser Co., Ltd is recalling seven Nice Station Light Based Platform surgical lasers because the required laser safety certification label was not affixed to the product.
Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.
IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System because the battery indicator may incorrectly display orange when the battery is fully charged.
Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Cards because the box label incorrectly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCA).
Beijing Syntech Laser Co., Ltd is recalling 13 Diode Laser surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
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