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.
A locking screw in the A.L.P.S. mvX Medial Tibia Plate may pass through its locking hole during surgery. Surgical delays have been reported with this device.
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.
Tyber Medical is recalling 408 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate because the locking screw can pass through the locking hole during surgery, causing surgical delays. No injuries have been reported.
GE Healthcare MRI systems may incorrectly resume scans after power loss when tissue heating rates exceed safe limits, risking excessive heating if patients contact conductive materials or have implants.
Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing through the locking hole during surgery, causing surgical delays.
Rajbhog Sweets Jelebi Yellow is recalled due to undeclared milk, a major allergen. The voluntary recall affects 531 lbs distributed in Texas.
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.
OCBW INC is recalling Beverage Base Lemonade products due to undeclared Yellow #5. A total of 8,847 units were distributed across eight states. Consumers with sensitivities to food dyes should not consume the product.
V Chocolates, Inc is recalling Assorted Chocolate Caramels with kosher sea salt due to plastic pieces from a broken tray. Consumers should not consume this product and should dispose of or return it.
Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.
Deiorio Foods is recalling 1701 cases of 5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shells due to potential contamination with white plastic fragments. The product may pose a choking hazard.
Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can pass through the locking hole during surgery, causing surgical delays.
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No injuries have been reported.
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
Rece International Corp. is recalling ViaMed Alcohol Prep Pads due to lack of sterility assurance and manufacturing process deviations. The affected product was distributed in Florida.
Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.
Idaho Pacific Fine Potato Flour has been recalled due to undeclared milk content (13-17 ppm) not listed on the label. Consumers with milk allergies should not consume this product.
GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.
Rajbhog Sweets Jelebi Orange is being recalled due to undeclared milk. Consumers with milk allergies should not consume this product.