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.
Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.
Ritmed Neurological Sponges are being recalled because they may not consistently meet the endotoxin specification for devices that contact cerebrospinal fluid. Ten units are affected.
Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.
Medline procedure kits including adult tracheostomy tube insertion, T&A and ear packs are being recalled because sample catheters did not meet performance specifications. 217,390 units affected.
Medline C-section kits, packs and recovery kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
The Medline EBSI Kit, EBSI1534, is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Medline C-Section Kits and Packs are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Port A Cath convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Kit: Dressing Change Ped is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Block Tray and Indwelling Nerve Block kit 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 of the potential for paint delamination, meaning chipping or peeling, on the light heads. 4,138 units affected.
The Medline Driveline Management Kit and Port Dressing Change Kit are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
ALYON Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 549 units are affected.
Medline convenience kits including abdominal, bariatric and laparoscopic cholecystectomy packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline da Vinci, general robotics and gynaecology laparoscopy convenience kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Labor & Delivery C-Section convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.
Medline convenience kits including pacemaker, ICD, open heart and pediatric open heart packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
Medline convenience kits for discectomy, ear, ENT and head and neck procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Medline convenience kits including AV fistula, endovascular, EP device and aneurysm packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Hysterectomy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Breast-Hernia-Port CDS-LF kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
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