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.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.
Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.
Spacelabs Healthcare is recalling 142 Sentinel V11 cardiology information systems because patient demographics may default to a previous patient and test data may be saved under another patient's record.
B-K Medical is recalling 1,697 Ultrasound System 1300 bkSpecto units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 496 bk3000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 124 bk3500 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 895 bk5000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.
Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.
Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.
IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.
IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.
IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.
IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.
Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 2,450 8-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
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