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.

17551–17575 of 27263

  • SevereFDA (Food)·F-0743-2023·2023-04-19

    Kagome Chuno Sauce Recalled for Undeclared Soy Allergen

    Mutual Trading Company is recalling Kagome Chuno Sauce (10 fl oz bottles, 51 cases) distributed to select U.S. states due to undeclared soy allergen, which poses serious health risks for allergic consumers.

    Product
    Kagome Chuno Sauce 30/10 fl oz Stock#24269 Ingredients: Tomato, Apple, Carrot, Brewed Vinegar, Sugar, Glucose, Salk, L-Glutamic Acid, Spice, Corn Starch, Fermented Seasoning, Xanthan Gum, Licorice. Imported By Mutual Trading Co., Inc. El Monte, CA 91731 North American Food Dist.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0701-2023·2023-04-19

    Organic Sliced Strawberries Recalled for Potential Hepatitis A Contamination

    California Splendor, Inc. is recalling 400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated due to potential Hepatitis A contamination. Product distributed to Oregon and California; consumers should not consume.

    Product
    400-lb. drums of 39+1 Organic Sliced Strawberries Refrigerated
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0744-2023·2023-04-19

    Kagome Tonkatsu Sauce Recalled Due to Undeclared Soy Allergen

    Mutual Trading Company Inc. is recalling Kagome Take Out Tonkatsu Sauce (STOCK #24274) because it contains an undeclared soy allergen. The recall affects 393 cases distributed to CA, AZ, NZ, TX, NM, OK, and HI.

    Product
    Kagome Take Out Tonkatsu Sauce STOCK: #24274 40 packets (8g) in a plastic bag. 15 bags in a box
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0703-2023·2023-04-19

    Frozen Organic Strawberries Recalled for Potential Hepatitis A Contamination

    Frozen Organic Strawberries sold under multiple brands (Kirkland Signature, Trader Joe's, and others) are being recalled due to potential hepatitis A contamination. Do not consume; discard or return to retailer.

    Product
    Frozen Organic Strawberries, Kirkland Signature, frozen, net wt. 4lb., 9 packages per case, Costco Item 904984. UPC 096619140404. Distributed by Costco Warehouse Corporation, Seattle, WA. Product of Mexico.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0704-2023·2023-04-19

    Trader Joe's Frozen Tropical Fruit Blend Recalled for Hepatitis A Risk

    Scenic Fruit Company is recalling Trader Joe's Organic Tropical Fruit Blend and related products distributed nationwide and regionally due to potential Hepatitis A contamination from Mexican strawberries. Five lot numbers with Best By dates from April to June 2024 are affected.

    Product
    Trader Joes Organic Tropical Fruit Blend, frozen, net wt. 16 oz., 24 bags per case, SKU 051191. UPC 00511919. This product contains strawberries from Mexico. Distributed by Trader Joe's Monrovia, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2023·2023-04-19

    Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk

    Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0708-2023·2023-04-19

    Biltmore Smoked Sockeye Salmon Recalled for Potential Listeria Contamination

    Seven Seas International USA LLC is recalling Biltmore Smoked Sockeye Salmon 4 oz packages due to potential Listeria monocytogenes contamination. Lot R4058 with expiration 03-31-2024 is affected.

    Product
    Biltmore Smoked Sockeye Salmon - 4 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1389-2023·2023-04-19

    Chromic Gut Absorbable Sutures recalled due to sterilization failure

    Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.

    Product
    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0722-2023·2023-04-19

    Meal Kits With Animal Crackers Recalled for Metal Shavings

    E S Foods is recalling meal kits nationwide due to potential bronze metal shavings in the animal crackers component. No illnesses have been reported.

    Product
    61119 RS Cinnamon Toast Crunch BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2023·2023-04-19

    Inflatable Penile Prosthesis Pump Risk of Premature Failure

    Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.

    Product
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2023·2023-04-19

    Meal Kits Recalled Due to Potential Metal Shavings in Animal Crackers

    E S Foods is recalling meal kits nationwide due to potential bronze metal shavings in animal crackers. The recall affects approximately 1,044,918 units.

    Product
    61520 Cheese Stick with 2 Grains and 1 Cup Fruit MB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2023·2023-04-19

    Mini Animal Graham meal kits recalled for bronze metal shavings

    E S Foods is recalling 61288 Mini Animal Graham Cinnamon SB meal kits nationwide because they may contain bronze metal shavings. Consumers should not eat affected products.

    Product
    61288 Mini Animal Graham Cinnamon SB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0726-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled for Metal Shaving Contamination

    E S Foods is recalling animal crackers in meal kits nationwide due to potential bronze metal shavings. Consumers should not consume affected products and should return them to retailers.

    Product
    61246 Cheerios Cereal Bar BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0725-2023·2023-04-19

    Nutri-Grain Bars in Meal Kits Recalled for Possible Metal Shavings

    E S Foods is recalling approximately 1 million Nutri-Grain Bar meal kits nationwide due to possible bronze metal shavings. Do not consume.

    Product
    61237 Nutri-Grain Bar, Strawberry BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2023·2023-04-19

    Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk

    Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.

    Product
    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0727-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled for Possible Metal Contamination

    E S Foods is recalling 1,044,918 meal kits containing animal crackers distributed nationwide due to potential bronze metal shaving contamination. No illnesses have been reported.

    Product
    61247 Pop-Tart Fudge BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2023·2023-04-19

    Medical X-ray Systems Recalled for Electrical Fire Hazard

    Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.

    Product
    CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2023·2023-04-19

    Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

    Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

    Product
    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2023·2023-04-19

    Step Bladeless Trocars recalled for sterilization failure

    Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

    Product
    Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

    Product
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2023·2023-04-19

    Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients

    Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.

    Product
    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.

    Product
    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide