Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.
Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.
Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.
Maquet Medical Systems USA is recalling the CARDIOHELP-i System because measured patient leakage current in some units significantly exceeded expected safety levels.
Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.
Macherey Nagel urinalysis test strips are recalled due to a missing leukocytes test pad on some packages, potentially resulting in false negative results for urinary tract infections and renal inflammation. Affected lot: 65402.
Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.
Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.
TriMed Inc. is recalling 142 units of Threaded IM Nails with an out-of-specification driver-socket that could prevent proper surgical nail fixation and torque application.
CN Frozen Foods is recalling Sysco Classic Riced Cauliflower sold in Texas due to Listeria monocytogenes contamination detected during testing. No illnesses have been reported.
Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.
Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.
TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.
LeMaitre Vascular is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide because the guide tip can become damaged and detach during use.
Kano Laboratories is recalling Super Lube Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor products in sizes of five gallons or less because the packaging is not child-resistant as required by law, posing a poisoning risk to young children.
CHZHVAN combination smoke and carbon monoxide detectors can fail to activate and may not alert users to a fire. About 6,800 units sold online via Amazon.com from August 2023 through January 2024 are affected.
Sacramento Cookie Factory is recalling Java Wafer - Mocha Hazelnut cookies because they contain undeclared milk, a common allergen that poses a health risk to people with milk allergies.
Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.
GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.
DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.