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.

17576–17600 of 27263

  • HighFDA (Food)·F-0707-2023·2023-04-19

    Impossible Chicken Nuggets Recalled for Possible Wood Fragments

    Impossible Foods Inc is recalling 128,029 cases of Impossible Chicken Nuggets nationwide due to possible wood fragments in the product, which pose a choking and injury risk.

    Product
    Impossible Chicken Nuggets Made From Plants, 2x5 lb Bags. Item No. 60-00031. Net Wt.: 10 lb (4.5kg). Not for retail sale. Fully Cooked. Perishable, Keep Frozen. Distributed by: Impossible Foods, Inc., Redwood City, CA 94063.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling 15 units of the Titan Touch Infr Zero Ang inflatable penile prosthesis (Lot Numbers 8849582, 8849603, 8904185) worldwide due to decreased wall thickness that may cause premature pump failure.

    Product
    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2023·2023-04-19

    Zone Perfect Fudge Graham bars recalled for hard plastic fragments

    Abbott Laboratories is recalling Zone Perfect Fudge Graham bars due to potential hard plastic fragments in the product. Affected bars were distributed to 36 U.S. states.

    Product
    Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1386-2023·2023-04-19

    Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

    Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1371-2023·2023-04-19

    Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

    Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.

    Product
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

    Product
    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2023·2023-04-19

    Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect

    Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.

    Product
    Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2023·2023-04-19

    Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk

    The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.

    Product
    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0723-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled Due to Possible Metal Shavings

    E S Foods is recalling animal crackers in meal kits distributed nationwide because they may contain bronze metal shavings that could cause choking or internal injury if ingested.

    Product
    61151 Apple Muffin Top TSMB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2023·2023-04-19

    Titan inflatable penile prosthesis recalled due to premature pump failure risk

    Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.

    Product
    Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2023·2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Food)·F-0717-2023·2023-04-19

    Butterball Turkey Stick Meal Kits Recalled for Possible Metal Shavings

    E S Foods is recalling Butterball Turkey Stick meal kits nationwide due to possible bronze metal shavings in the animal crackers. Consumers should not consume these products.

    Product
    61404 Butterball Turkey Stick MB (meal box)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0803-2023·2023-04-19

    Protein bars recalled nationwide for undeclared cashew allergen

    Wellness Natural USA Inc. is recalling SimplyProtein peanut butter chocolate crispy bars sold at Costco due to undeclared cashew allergen. 2.46 million boxes are affected.

    Product
    SimplyProtein¿ Peanut Butter Chocolate Crispy 15-1.41 OZ (40 g) bar. (UPC 6 86207 00914 7) Sold in 15-count variety pack with two other flavors (Lemon Coconut and Chocolate Sea Salt) NET WT 21/16 OZ (600 g). Outside carton UPC 6 86207 80906 8. Packaged in a carboard box. Indiv
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2023·2023-04-19

    Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect

    Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.

    Product
    Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0706-2023·2023-04-19

    Impossible Chicken Nuggets Recalled Nationwide for Wood Contamination

    Impossible Foods is recalling 128,029 cases of Impossible Chicken Nuggets nationwide due to potential wood contamination. The products should not be consumed.

    Product
    Impossible Chicken Nuggets Made From Plants packaged in the following names and package sizes: 1. Wild Nuggies, Net Wt. 13.5oz (383g), UPC 8 16697-02039 5; 2. Chicken Nuggets, Net Wt. 32 oz (907g), UPC 8 16697-02042 5; 3. Chicken Nuggets, Net Wt. 13.5oz (383g), UPC 8 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0715-2023·2023-04-19

    Frozen Raspberries Recalled Due to High Levels of Mold

    Multiple frozen raspberry products from B.C. Frozen Foods (Nature's Promise Organic, Stater Bros., SB, and Sunny Select brands) are being recalled due to high levels of mold contamination.

    Product
    1. Nature's Promise Organic Raspberries 10oz; Stand up plastic pouch in corrugated box; Product of Chile; 8x12 oz bags per case; 2. Stater Bros. Red Raspberries 12oz; Stand up plastic pouch in corrugated box; Product of USA; 12x12 oz bags per case; 3. SB Raspberries 12 oz; Stan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1388-2023·2023-04-19

    Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk

    Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.

    Product
    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2023·2023-04-19

    Cheese Cup Meal Kits Recalled Due to Metal Shavings in Animal Crackers

    E S Foods is recalling 61490 Cheese Cup with 2 Grains meal kits because the animal crackers may contain metal shavings. These products were distributed nationwide.

    Product
    61490 Cheese Cup with 2 Grains MB (meal box)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0724-2023·2023-04-19

    Meal kits with animal crackers recalled for potential bronze metal shavings

    E S Foods is recalling 1,044,918 meal kits sold nationwide. The animal crackers in these kits may contain bronze metal shavings, which could cause injury if consumed.

    Product
    61152 Smart Choice Chocolate Chip Muffin TSMB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2023·2023-04-19

    X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge

    Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.

    Product
    ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
    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
  • 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-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide