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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.
Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.
GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.
Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.
Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.
GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.
ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.
Stradis Medical recalled 790 Foundation Kits because the manufacturer cannot confirm tenaculum devices met design and manufacturing standards.
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.
Stradis Medical is recalling 1,639 Endometrial Biopsy Kits nationwide because the manufacturer cannot confirm the tenaculum devices meet required design and manufacturing standards.
GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.
GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.
Bard Peripheral Vascular Inc. is recalling 360 Jamshidi Bone Marrow Biopsy Trays (Catalog # BEK3411, Lot # 0001378561) due to misbranded labeling. The FDA classified this as a Class II recall affecting healthcare facilities in 16 U.S. states and Puerto Rico.
Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.
Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
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