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.
A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.
Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.
The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.
A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.
Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.
GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch due to pairing difficulties that may delay surgical procedures.
The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.
Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.
Lineage Biomedical is recalling NavaClick Syringe and Needle Model LIN02 due to an incorrect GTIN number on carton packaging. The recall affects 215 cartons distributed in Michigan and South Carolina.
Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.
Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.
The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.
Some lots of the Capio SLIM suture capturing device may fail to consistently catch sutures during surgery, potentially requiring extended procedures or additional medical intervention.
Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.
The SlideView VS200 slide viewer has a broken laser fuse caused by a short circuit from a poorly positioned cable. This prevents the shutter from operating properly, leaving it stuck in an open or closed position.
Looking for a different category? Browse all recalls.