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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.
Ventec Life Systems is recalling VOCSN+Pro respiratory systems due to a damaged backup battery that may prevent the backup alarm from activating during power loss, delaying caregiver awareness of a hazardous condition.
Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.
Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.
Medline Industries is recalling four models of Convenience Kits containing Lidocaine and Bupivacaine injections due to quality issues identified during an FDA inspection of the supplier.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and to Barbados.
Medline Industries is recalling two models of Convenience Kits (ACC011142 and DYNJ8407) distributed nationwide. The kits contain injectable anesthetics that were recalled due to quality issues found during an FDA inspection of the supplier.
Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.
Medline Industries is recalling 22 models of Convenience Kits that contain Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection due to quality issues found during an FDA inspection of the supplier.
Medline Industries is recalling Medline Convenience Kits (models DYNJ905503F and DYNJ905503G) that contain Arrow Kits with Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection due to quality issues found during an FDA inspection of the supplier.
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 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.
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 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.
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 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 MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.
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.
Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.
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.
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.
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 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.
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