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.
Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because the external screws securing the cover to the saw housing may loosen and detach during use.
Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.
Elekta is recalling Leksell Gamma Knife radiosurgery systems, covering the Perfexion, Icon and Elekta Esprit models, due to an adapter not being properly aligned or locked in place.
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
GE Medical Systems is recalling Centricity Universal Viewer software versions 7.0 through 7.0 SP2.0.1 because user login credentials may be exposed on the local client workstation.
Diagnostica Stago is recalling the STA Liatest D-Di kit after investigations confirmed a positive bias in D-dimer measurements throughout the entire analytical range.
ConvaTec is recalling two lots of the EsteemBody Drainable Pouch, REF 423643, because the drainable large pouch may leak due to a manufacturing issue.
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423653, because the drainable large pouch may leak due to a manufacturing issue.
GE Medical Systems is recalling Centricity Universal Viewer software versions 5.0 SP6 through 5.0 SP7.1 because user login credentials may be exposed on the local client workstation.
GE Medical Systems is recalling Centricity Universal Viewer software versions 6.0 through 6.0 SP10.4.1 because user login credentials may be exposed on the local client workstation.
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423657, because the drainable large pouch may leak due to a manufacturing issue.
Baxter is recalling the Welch Allyn Spot Vision Screener VS100 on software version 3.2.0.1 because the display screen may unintentionally flicker, which may induce photosensitive seizure activity.
Datascope is recalling the Battery Charging Station, model 0998-00-0802, because a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging.
LeMaitre Vascular is recalling one Artegraft Vascular Graft, REF AG740, because of a labeling mix-up resulting in the incorrect lot outer packaging of the product.
Stryker is recalling Cub Pediatric Cribs, model FL19H, because cribs sold in the USA are missing two access door warning labels.
Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.
Trividia Health is recalling owner's booklets and instructions for TRUE METRIX PRO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.
Trividia Health is recalling owner's booklets and instructions for TRUE METRIX blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.
Trividia Health is recalling owner's booklets and instructions for TRUE METRIX AIR blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8030/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2835/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Medline is recalling Medcrest surgical gowns because the fabric may delaminate prematurely when the included laundering instructions are followed.
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