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.
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may fail to cut, coagulate, or blend during procedures.
NDDd Medical Technologies is recalling 37 EasyOne Pro Respiratory Analysis Systems because the CO/CO2 sensor cable harness may have insufficient electromagnetic shielding.
NDDd Medical Technologies is recalling 37 EasyOne Pro LAB VOS devices due to potential non-compliance with electromagnetic shielding standards.
Brasseler USA is recalling 387 units of 3.5 mm twist drills that were incorrectly laser etched as 2.5 mm.
Miami Device Solutions is recalling 15 units of Right Proximal Humerus Plates because they may be improperly identified as left.
Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.
Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.
Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.
Zimmer Biomet is recalling 73 units of the ASI 2.0 Calcar Trimmer Shaft because the shaft end may fail to mate effectively with the broach.
Zimmer Biomet is recalling Compress Mini Compress devices because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.
Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.
GN Hearing is recalling 285 in-the-ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.
Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Zimmer Biomet is recalling various hip arthroplasty systems because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Vital Scientific N.V. is recalling 732 V-Twin instruments in New York due to a risk of aspirating samples from the wrong container, which could lead to incorrect patient reports.
Zimmer Biomet is recalling Hennessy Left Constrained Glenoid Humeral Shoulder Implants due to elevated bacterial endotoxin and residual debris caused by a cleaning issue.
Zimmer Biomet is recalling 2.0mm Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.
GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.
Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
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