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.
Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.
Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.
C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.
Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.
Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.
C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.
C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.
Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.
GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.
C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.
North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.
Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.
Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.
Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.
Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.
Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.
Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.
Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.
Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.
Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.
Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
Looking for a different category? Browse all recalls.