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.
GE Healthcare is recalling Legacy and other imaging systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.
GE Healthcare is recalling Prestige SI and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and overseas.
PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.
Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.
Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.
Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.
Shimadzu Medical Systems is recalling 39 SONIALVISION G4 X-ray TV Systems due to a potential oil leak from the x-ray tube housing.
Sterling Diagnostics is recalling 165 Colorimetric SGOT diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 97 units of Enzymatic Cholesterol diagnostic kits due to a revision of previously extended expiration dates.
Sterling Diagnostics is recalling Serum Iron/IBC diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 182 units of Creatinine/Endpoint diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 40 units of Enzymatic Glucose diagnostic kits due to a revision of previously extended expiration dates.
Sterling Diagnostics is recalling SGPT Colorimetric kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded. The kits were distributed in Michigan and the Philippines.
Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.
Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.
The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.
Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.
Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.
Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.
Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.
Medtronic is recalling 315 units of the PowerCross .018 OTW PTA Dilatation Catheter due to a manufacturing defect causing the balloon to fail to inflate or deflate properly.
Oscor, Inc. is recalling 45 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
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