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.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.
Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.
Smiths Medical ASD Inc. is recalling 16 Bivona Tracheostomy Tubes because the cartons are labeled 'Sterile' even though the devices are not sold as sterile.
Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.
MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.
C.R. Bard is recalling specific lots of Bardex Foley catheters because the retainer cap print is incorrect.
NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.
Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.
Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.
NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.
Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.
Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.
Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Hobbs Medical is recalling 1,820 bronchial cytology brushes because they were marketed for uses outside their FDA clearance.
Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.
Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.
Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.
Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.
WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen sterile surgical gloves because some left-handed gloves contain powder, which is banned in the U.S.
Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.
Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.
Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.
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