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.
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.
TOHATO Nagewa Snack Seaweed Flavor contains undisclosed milk and shellfish allergens. The product is distributed to Daiso stores in CA, WA, Nevada, TX, NY, and NJ; consumers with these allergies should not consume.
Caramel Corn The Star Festival 80g units are recalled because they contain almonds that are not listed on the ingredient label. About 317,751 units were distributed to Daiso stores in six U.S. states and Canada.
TOHATO Bitter Caramel Corn 77g units are recalled because they contain almonds not listed on the ingredient label. This poses a serious risk to consumers with almond allergies.
TOHATO Caramel Corn products sold at Daiso stores are being recalled because almonds are present but not listed on the ingredient label, posing risk to people with almond allergies.
Daiso California Warehouse is recalling Tohato Caramel Corn 5-packs because almond appears in the ingredient list but is missing from the allergen Contains statement. Consumers with almond allergies who rely on the allergen statement may unknowingly consume this product.
Tampico Spice Company Inc is recalling Cayenne Pepper in 1-pound and 5-pound jars due to elevated aflatoxin levels. The affected lot is #2112245, distributed across eight states.
Rising Pharmaceuticals is recalling Warfarin Sodium Tablets USP 1 mg due to failed impurities and degradation specifications. Approximately 12,216 bottles may have been distributed nationwide.
BAKE'N JOY FOODS is recalling Gordon Choice Cranberry Orange Flavored Nut muffin batter due to undeclared soy lecithin. Consumers with soy allergies face a reaction risk.
Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.
Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.
Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.
Tampico Spice Company is recalling Cajun Seasoning in multiple sizes due to elevated aflatoxin contamination. Affected lots were distributed across eight states.
IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.
Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.
Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.
IBSA Pharma has recalled two lots of TIROSINT levothyroxine sodium oral solution nationwide because they contain less active ingredient than labeled. The affected lots are 220409 (expiring 10/2023) and 220956 (expiring 03/2024).
Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.
IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains less active ingredient than labeled.
TIROSINT (levothyroxine sodium) oral solution has been recalled nationwide by IBSA Pharma Inc. due to subpotency, with the affected medication containing less active ingredient than labeled.
Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.
B. Braun Medical is recalling 0.9% Sodium Chloride Injection due to possible incomplete container seals that may leak. The recall involves 483,229 bags distributed nationwide.