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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.
FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.
Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.
HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.
GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.
Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.
Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.
A Corin MetaFix hip stem (size 7 collarless) was incorrectly labeled as a size 3 collared stem with wrong batch information. The labeling error creates risk during surgical implantation.
Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.
Approximately 7,218,000 Haiou Needle Retractable Safety Syringes are being recalled due to needle detachment and retracting mechanism failures that increase needlestick injury risk. The affected product was distributed in California.
Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.
Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.
Craftmatic Industries is recalling the Model 1 Base for Dual Bed Configurations due to a potential for the bed bases to separate or slip apart. This defect could cause dual-configured beds to shift unexpectedly.
Dental Choice is recalling 708 units of the CustMbite Model CBT-SRS-UL device nationwide because it was marketed and sold without FDA clearance.
Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.
St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.
The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.
Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.
Malvern Panalytical is recalling 507 NanoSight NS300 units due to noncompliance with Class 1 laser safety requirements. The device may not meet established safety standards for laser-based instruments.
Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.
St. Jude Medical recalls Merlin 2 PCS model MER3700, software used to program and interrogate Abbott implantable medical devices.
St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.
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