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.
C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.
Baxter Healthcare is recalling the Novum IQ LVP Infusion System because the device may deliver less medication than intended when using standby mode or after being powered off with the set loaded.
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because affected units may have open seals on the packaging, compromising sterility assurance.
Organic Traditions brand Jumbo Pumpkin Seeds (227g/8oz, UPC 6 27733 00175 5) are being recalled due to potential Salmonella contamination. Affected units were distributed in NY, NJ, and VA.
Frobright Salsary, LLC is recalling Verde Salsa due to potential contamination with wood particles. The recall affects 12.5 oz containers distributed in Alaska, Idaho, Oregon, and Washington.
Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.
Frobright Salsary, LLC is recalling San Juan Salsa Medium Salsa (14 oz containers) due to potential contamination with wood particles. The product was distributed in Alaska, Idaho, Oregon, and Washington.
AstraZeneca is recalling AIRSUPRA (albuterol sulfate and budesonide) inhalation aerosol due to a defective delivery system. The recall affects multiple lot numbers and expiration dates distributed nationwide.
Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.
Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.
Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.
Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.
Frobright Salsary, LLC is recalling Pineapple Mango Salsa due to potential contamination with wood particles. The 13 oz containers were distributed in Alaska, Idaho, Oregon, and Washington.
Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
San Juan Medium Salsa 32 oz containers sold at Costco are being recalled due to potential contamination with wood particles. The affected product was distributed in Alaska, Idaho, Oregon, and Washington.
Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (6.4 oz, Lot B0067, expiring 08/31/2026) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.