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.
The MOSAIQ Oncology Information System is being recalled because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.
Allia Moveo angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. Three units affected.
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
MIC Safety PEG Kits with ENFit Connectors, 24 Fr PULL, catalog number 8180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 72 kits affected.
MIC Safety PEG Kits with ENFit Connectors, 20 Fr PUSH OTW, catalog number 8170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.
Halyard Drape Packs, kit code LMDP36-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 72 kits affected.
An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.
MIC Safety PEG Kits, 14 Fr PULL, catalog number 7180-14, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 208 kits affected.
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.
TDC VELOCE 27G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
MIC Safety PEG Kits, 24 Fr PULL, catalog number 7180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 1,006 kits affected.
Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 49 kits affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
MIC Safety PEG Kits, 24 Fr PUSH OTW, catalog number 7170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 132 kits affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Hintermann Series Talar Implants, Left, Size 2, are being recalled because packaging and labeling for a left implant contained a right implant device. 67 units are affected.
Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
Plum Duo Infusion Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Plum Solo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
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