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.
Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.
Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.
Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.
Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.
Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.
Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.
Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.
Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.
Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.
Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.
Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.
Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.
Siemens is recalling RAPIDPoint 400 Measurement Cartridges because of an error in the value assignment for Chloride calibrators.
Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.
Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.
The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.
The Anspach Effort, Inc. is recalling 1,833 Small Battery Drive adaptors worldwide because they may generate excessive internal pressure and burst.
Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.
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