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 Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.
HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.
Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.
Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 units affected.
ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 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 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.
Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are affected.
Medline Tonsil Pack Cath procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 384 units are affected.
ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.
Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.
Giraffe OmniBed Carestations are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 23,430 units 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.
Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.
ConMed AirSeal 8 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 Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.
STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.
Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.
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.
Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.
Merit Medical Splashwire Hydrophilic Guide Wires are being recalled because of unsealed portions of pouches. 5,004 units are affected.
Ritmed non-sterile Neurological Sponges across seven sizes are being recalled because they may not consistently meet the endotoxin specification for devices contacting cerebrospinal fluid.
Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.
Giraffe OmniBed Field Replaceable Units are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 265 units affected.
Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.
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