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.
MTI Precision Products LLC is recalling 134 Lynx TM20 Torquemaster Low Speed Handpieces due to a sharp edge on the body or housing.
Siemens Healthcare Diagnostics Inc is recalling six RAPIDComm Data Management Systems because the 5.0 screen layout displays incorrect test names.
Siemens Medical Solutions USA is recalling 2,458 e.cam camera systems because the collimator cart rear casters may become loose.
Becton Dickinson is recalling specific lots of BBL CrystaLEAD E/NF Identification kits because some contain fluid bottles that expire before the date printed on the kit carton.
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.
Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.
B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.
Pall Corporation is recalling specific lots of Medical Breathing Circuit Filters due to a possible leak at the filter end cap junction.
RGI Medical is recalling 19,200 units of Henora 300psi I.V. Catheter Extension Sets due to a defect that may cause the tubing to separate from the luer connection during use.
Vascular Technology, Inc. is recalling 25 VTI Bayonet Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.
Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.
Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.
Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.
Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.
Karl Storz Endoscopy is recalling 968 Essential NEO audio/visual integration units because the connected power cable could overheat, generate smoke, and cause the peripheral to stop working.
Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.
The FDA is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits because straps may separate from the foam pad.
Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.
Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.
Codan US Corporation is recalling ColorSafe IV lines because they were manufactured and marketed prior to FDA approval.
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