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.
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 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 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.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.
Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.
Zimmer is recalling the Off-Axis Comprehensive Shoulder System Small Reamer Guide due to plastic guides catching and breaking during reaming procedures.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Zimmer, Inc. is recalling the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Lot 66232947) after a complaint reported a posterior augment found inside the distal augment package.
Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.
IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
Pending LLM rewrite. Source: FDA_DEVICE Z-2364-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2359-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2446-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2419-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2489-2026.
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