The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

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.

20126–20150 of 88183

  • HighFDA (Devices)·Z-1210-2023·2023-03-15

    Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components

    DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.

    Product
    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0415-2023·2023-03-15

    Chili Pepper Powder Recalled for Undeclared Sesame Allergen

    Shirakiku brand Chili Pepper Powder (ICHIMI TOGARASHI) is being recalled nationwide and internationally because it contains sesame that is not declared on the ingredient label. Consumers with sesame allergies should not consume this product.

    Product
    Chili Pepper Powder (ICHIMI TOGARASHI) 300g UPC: 074410341169 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2023·2023-03-15

    CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions

    St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2023·2023-03-15

    Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration

    Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.

    Product
    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1232-2023·2023-03-15

    Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

    Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

    Product
    Cardiosave Rescue. Model Number: 0998-00-0800-83.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2023·2023-03-15

    FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations

    Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.

    Product
    Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2023·2023-03-15

    Monaco RTP System software may calculate radiation therapy doses inaccurately

    Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2023·2023-03-15

    Metformin Extended-Release Tablets Recalled for Excess NDMA Contamination

    Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.

    Product
    Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1213-2023·2023-03-15

    Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection

    Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.

    Product
    Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2023·2023-03-15

    CardioMEMS PA Sensor models affected by radio-frequency range at high elevations

    St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2023·2023-03-15

    CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations

    St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2023·2023-03-15

    Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure

    Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.

    Product
    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2023·2023-03-15

    Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification

    Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2023·2023-03-15

    Daily Harvest French Lentil Crumbles Recalled for Gastrointestinal Illness

    Daily Harvest French Lentil + leek Crumbles (Item L02-VEGBN) are being recalled due to complaints of gastrointestinal illness. The recall affects 28,776 units distributed nationwide with lot codes from September through November 2022.

    Product
    Daily Harvest French Lentil + leek Crumbles, Item ID L02-VEGBN, Net Wt. 12 oz. (340g) Keep Frozen, Cook Thoroughly. Perishable. Store Frozen. Cook Thoroughly to internal temperature of 165F. Distr. by Daily Harvest Inc. New York, NY 10013.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0434-2023·2023-03-15

    Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency

    B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0406-2023·2023-03-15

    Rao's Roasted Peppers with Portobello Mushrooms Recalled for Undeclared Pine Nuts

    Sunny Dell, Inc. recalls Rao's Homemade Roasted Peppers with Portobello Mushrooms (12 oz) for undeclared pine nuts. Product distributed to Northeast U.S. Consumers with pine nut allergies should be aware of this recall.

    Product
    Rao's Homemade Roasted Peppers with Portobello Mushrooms Net WT. 12OZ (340g) UPC:74749001106 Packaged in glass jars, 12 packages per cases
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2023·2023-03-15

    TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval

    A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.

    Product
    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1231-2023·2023-03-15

    Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

    Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2023·2023-03-15

    CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations

    Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2023·2023-03-15

    FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

    Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.

    Product
    Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0450-2023·2023-03-15

    FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations

    Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.

    Product
    Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide