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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.
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were distributed nationwide.
Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.
Surgify Medical is recalling Surgify Halo 3.0 mm Extendable surgical burrs because they may break during bi-portal endoscopic spinal surgery, posing a risk to patients.
Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.
TMJ Solutions Inc is recalling TMJ Bilateral Implants (REF: CHG020) because some units may contain incorrect patient-specific components, causing poor implant fit and right-sided open bite.
Zimmer is recalling the Off-Axis Alliance Glenoid Right 4-Peg Augment Reamer Guide (Model 110040476) after five complaints that plastic guides broke during reaming.
Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US states.
Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in loss of speaker output.
Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.
Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.
SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.
GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.
Surgify Halo 4.0 mm surgical drills are being recalled because the burr may break during bi-portal endoscopic spinal surgery. The defect could interfere with the surgical procedure.
Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.
Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.
Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. states.
Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.
Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.
Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.
Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.
Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System reamer guides (Model 110040242) due to plastic guides that can catch and break during reaming. Five complaints have been received.
Surgify Medical is recalling the Surgify Halo 5.4 mm surgical burrs due to potential breakage during spinal surgery procedures.
Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid Left 4-Peg Augment Reamer Guide because the plastic guides can catch during reaming and break. Five complaints have been received.
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.
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