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.
Medline da Vinci Main convenience kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline convenience kits including basic packs, general laparoscopy, CVC insertion bundles and da Vinci packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
The Medline IV Start Kit with HubGuard is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline SMSC Pelviscopy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Add-A-Cath Arterial Insertion kit and Ped School Age PICC Dressing Tray are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline Minor Cath Lab Packs, OR Vascular Angio Packs and Port-A-Cath kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline central line dressing kits, PICC/CVC/midline CHG dressing kits, port-a-cath kits and vein ablation packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
The Medline Basic Eye kit and Tubal Ligation CDS kit are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits for ACD, ACDF, ACL and ALIF procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits for breast imaging, plastics and facial procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline central venous catheter insertion kits and Vantex PI CVC bundles are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 2,101 units affected.
Medline CCI Nerve Block Trays and CPNB kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
The Medline WT LAVH Pack is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Centurion convenience kits including dialysis catheter maintenance and dressing change trays are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits for ACL, arthroscopy, back and paediatric procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline EBSI central line, CVC/PICC/midline and dialysis dressing change kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Femoral Block Tray is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline neurosurgery convenience kits including neuro packs, MRI DBS packs and VP shunt kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Hernia Repair Tote convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
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.
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
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.
Bicarby Dialysate across six model numbers is being recalled because luer-lock leaks during preparation present a potential slip and fall hazard from fluid on the floor.
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