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.

12901–12925 of 27263

  • SevereFDA (Devices)·Z-0939-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues

    Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.

    Product
    EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0928-2024·2024-02-07

    Monterey Jack Cheese Recalled for Listeria Monocytogenes Contamination

    Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.

    Product
    Monterey Jack Conventional (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0922-2024·2024-02-07

    Tio Francisco Queso Para Freir Recalled Due to Listeria Contamination

    Tio Francisco Queso Para Freir (frying cheese) is being recalled due to potential Listeria monocytogenes contamination. The recall affects multiple batches distributed across multiple U.S. states.

    Product
    Tio Francisco Queso Para Freir 16 oz. Tio Francisco Queso Para Freir Available to consumers at retail deli counters in various sizes Freir (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0805-2024·2024-02-07

    Multiple Tuna Products Recalled Due to Listeria Monocytogenes Contamination

    Ocean Group Inc. is recalling tuna products distributed in California due to potential Listeria monocytogenes contamination identified through FDA environmental sampling.

    Product
    201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BLUEFIN SPAIN G&G SPAIN F LB 201508 TUNA BLUE FIN GG JAPAN FR JPN F LB 201900 TU
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0919-2024·2024-02-07

    Queso Fresco from Multiple Brands Recalled for Listeria Contamination

    Rizo Lopez Foods, Inc. is recalling various queso fresco products from multiple brands due to potential Listeria monocytogenes contamination. The affected products were distributed to retail locations in multiple U.S. states.

    Product
    Tio Francisco, El Huache, La Ordena Fresco (Michoacano) Available to consumers at retail deli counters in various sizes Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Rizo Bros. Queso 8 oz. UPC 7-27242-00159-5 Don Francisco 10 oz. UP
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0925-2024·2024-02-07

    Ricotta cheese products recalled for Listeria monocytogenes contamination

    Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.

    Product
    365 Whole Foods Market Ricotta Part Skim 15 oz. UPC 9-94824-63052 365 Whole Foods Market Ricotta Whole Milk 15 oz. UPC 9-94824-96245 Ricotta Part Skim 65%, 70%, 75% Moisture (bulk)
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0920-2024·2024-02-07

    Oaxaca Cheese Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods recalled Oaxaca cheese products sold under multiple brand names due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states.

    Product
    Rizo Bros. Oaxaca 8 oz. UPC 7-27242-00334-6 Tio Francisco Oaxaca 12 oz. UPC 7-27242-12332-7 Tio Francisco Oaxaca 14 oz. UPC 7-27242-00532-6 Food City Oaxaca 16 oz. Tio Francisco, San Carlos Available to consumers at retail deli counters in various sizes Tio Francisco Oaxaca
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0804-2024·2024-02-07

    Salmon fillets recalled for potential Listeria monocytogenes contamination

    Ocean Group Inc. is recalling frozen salmon fillet products distributed in California due to potential Listeria monocytogenes contamination detected during FDA environmental sampling.

    Product
    202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB 202032 SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0817-2024·2024-02-07

    Melissa's Hot Kimchi Pickled Napa Cabbage Recalled for Undeclared Fish Allergen

    Melissa's Hot Kimchi Pickled Napa Cabbage is being recalled due to undeclared fish allergen. 124 cases were distributed to California, Texas, and Florida.

    Product
    Melissa's Hot Kimchi Pickled Napa Cabbage NET WT. 14 oz (397g) Ingredients: Napa Cabbage, Radish, Water, Garlic, Red Pepper, Organic Sugar Cane, Sea Salt, Calcium Lactate, Ginger, Onion, Sorbitol, and Xanthan Gum. Produce on equipment that also processes products containing fi
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0941-2024·2024-02-07

    Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures

    Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.

    Product
    EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2024·2024-02-07

    Tio Francisco Yogurt recalled for potential Listeria monocytogenes contamination

    Tio Francisco Yogurt products in multiple flavors are being recalled due to potential Listeria monocytogenes contamination. Consumers who have purchased these yogurts should not consume them.

    Product
    Tio Francisco Yogurt (Plain, Strawberry, Peach, Mango) Available to consumers at retail deli counters in various sizes
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0918-2024·2024-02-07

    Sour Cream Products Recalled for Listeria Monocytogenes Contamination

    Rizo Lopez Foods has recalled multiple sour cream and cream products due to Listeria monocytogenes contamination. Products were distributed across multiple U.S. states.

    Product
    Tio Francisco Crema Centroamericana 16 oz. UPC 7-27242-00440-4 Tio Francisco, Campesino Crema Centroamericana Available to consumers at retail deli counters in various sizes Tio Francisco Crema Latina 16 oz. UPC 7-27242-35445-5 Tio Francisco Crema Latina Available to consumer
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0278-2024·2024-02-07

    FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction

    FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.

    Product
    FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0924-2024·2024-02-07

    Rizo Lopez Tio Francisco Requeson Recalled for Listeria Contamination

    Tio Francisco Requeson cheese products are recalled due to Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the store.

    Product
    Tio Francisco Requeson 14 oz. UPC 7-27242-00390-6 Tio Francisco Requeson 15 oz. UPC 7-27242-00392-6 Tio Francisco Requeson Available to consumers at retail deli counters in various sizes
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0917-2024·2024-02-07

    Cheese product recalled for Listeria monocytogenes contamination

    Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.

    Product
    Tio Francisco Blanco Suave 14 oz. UPC 7-27242-05355-6
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0808-2024·2024-02-07

    Shennongyuan Dried Longan Recalled Due to Undeclared Sulfites

    J T Trading Inc. is recalling Shennongyuan Dried Longan due to undeclared sulfites. Consumers with sulfite sensitivities should not consume this product.

    Product
    Shennongyuan Dried Longan packaged in a silver metal box bulk 18kgs
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0864-2024·2024-02-07

    Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall

    The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.

    Product
    smiths medical Medfusion Model 4000 syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0933-2024·2024-02-07

    EZDilate esophageal balloons recalled for inflation failure and device leaking

    Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.

    Product
    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0916-2024·2024-02-07

    FDA Recalls Cotija Cheese for Listeria Monocytogenes Contamination

    Rizo Lopez Foods recalls multiple brands of cotija cheese due to potential Listeria monocytogenes contamination. Products were distributed through retail deli counters across 20 U.S. states.

    Product
    Rizo Bros Cotija (Grated) 8 oz. UPC 72724200043 7 oz. UPC 7-27242-14022-5 Tio Francisco, Casa Cardenas 9 oz. UPC 7-27242-00022-2 & 8-11371-27109-4 Rizo Bros Cotija 8 oz. UPC 7-27242-00043-7 Tio Francisco Cotija 14 oz. 7-27242-00517-3 Food City Cotija 16 oz. Tio Francis
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0775-2024·2024-02-07

    FDA recalls EVair 03 compressor models for elevated formaldehyde levels

    FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).

    Product
    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0774-2024·2024-02-07

    EVair Air Compressors Recalled for Elevated Formaldehyde Emissions

    EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.

    Product
    EVair air compressor, model numbers: M1230849 and M1230847
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0923-2024·2024-02-07

    Tio Francisco Queso Seco Cheese Recalled for Listeria Monocytogenes

    Rizo Lopez Foods is recalling Tio Francisco Queso Seco 14 oz. cheese due to Listeria monocytogenes contamination. The product was distributed across multiple U.S. states with production dates through July 31, 2024.

    Product
    Tio Francisco Queso Seco 14 oz. UPC 7-27242-00548-8
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0281-2024·2024-02-07

    Vancomycin IV bags recalled due to filling system malfunction causing double doses

    Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.

    Product
    VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
    Category
    Drug
    Distribution
    Distributed nationwide