Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Novartis is recalling specific lots of Diovan (valsartan) 160 mg tablets because they failed to meet required dissolution specifications.
W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.
Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.
Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP 1.00KG bags due to CGMP deviations noted during an FDA inspection.
Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.
Heritage Pharmaceuticals is recalling Clindamycin Palmitate Hydrochloride oral solution due to the presence of particles and white flakes in reconstituted bottles.
Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.
The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.
Straumann USA LLC is recalling 417 GM Helix dental implants because the implant inside the packaging may not match the outer carton label, potentially causing installation issues.
W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.
Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.
Spacelabs Healthcare is recalling 6,074 Xhibit Central Station units because an off-the-shelf DisplayPort audio/video splitter component may fail.
FlavorsandColor.Com is recalling 80 cases of Honeyville Yellow Color 1 Gallon due to undeclared Red #40. The product was distributed to 12 locations in four states.
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
Blank Slate Creamery is recalling 66 units of vegan coconut fudge sandwiches sold in Michigan due to undeclared egg.
Clover Hill Dairy, LLC is recalling its Mild Cheese Variety (3-in-a-pack assorted White Colby, Marble Jack, Yummy Cheddar) because the product may be contaminated with Listeria monocytogenes. The recall affects products distributed in MD, VA, and NY.
Sunny Pharmtech Inc. is recalling 4,077 vials of Cyclophosphamide for Injection due to stainless steel particulate matter found in the product. The recall affects vials distributed nationwide in the USA.
AVID Medical, Inc. is recalling Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because particulates may be present in the fluid path.
Clover Hill Dairy, LLC is recalling various Pepper Jack cheese varieties because they may be contaminated with Listeria monocytogenes.
Clover Hill Dairy, LLC is recalling its sharp cheese varieties due to potential contamination with Listeria monocytogenes. The recall affects products distributed in MD, VA, and NY.
Pride Mobility Products Corp. is recalling Quantum Rehab Q6 Edge 4 powered wheelchairs because a software issue can cause unexpected braking and potential injury.
Kerry, Inc. is recalling KC Everyday Mac & Cheese because it contains an undeclared egg allergen. The product was distributed in five states.
Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.