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.

19176–19200 of 88183

  • SevereFDA (Food)·F-0749-2023·2023-05-03

    Lamb Weston Frozen Hash Brown Patties Recalled for Undeclared Wheat

    Lamb Weston Sales is recalling frozen hash brown patties due to undeclared wheat allergen. The recall affects approximately 1605 cases distributed to foodservice customers across multiple states and international locations.

    Product
    G5300 Lamb's Supreme Hash Brown Patties, Frozen, 24 patties packed in blank unlabeled tray, 12 trays packaged in one case. Net Wt. 33.75LB (15.30kg). UPC 1 00 44979 75300 7. The ingredients statement read: POTATOES, VEGETABLE OIL (CONTAINS OR OR MORE OF THE FOLLOWING: CANOLA…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0755-2023·2023-05-03

    Premium Makoto Honey Ginger Salad Kit Recalled for Listeria Contamination

    Fresh Express is recalling Premium Makoto Honey Ginger Salad Kits distributed in five states because the product tested positive for Listeria monocytogenes. Consumers should not consume this product.

    Product
    PREMIUM MAKOTO HONEY GINGER SALAD KIT TOTAL NET WT 8.75 OZ (248g) DRESSING 2.03 FL OZ (60 mL) SALAD & TOPPING 6.5 OZ (184g) DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., LAKELAND, FL 33802 UPC 0 41415 18386 5
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0753-2023·2023-05-03

    Fresh EXPRESS Lettuce Salad Kit Recalled for Listeria

    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce has been recalled due to testing positive for Listeria monocytogenes. The affected product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce TOTAL NET WT. 9.4 OZ (266g) SALAD & TOPPINGS: NET WT. 6.9 OZ (196g) DRESSING 2.5 fl. oz. (74 mL)/NET WT 2.5 oz. (71g) fresh express incorporated P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30919 4
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0754-2023·2023-05-03

    Fresh Express Chopped Kit Recalled for Listeria monocytogenes

    Fresh Express Chopped Kit Chipotle Cheddar salad has been recalled because it tested positive for Listeria monocytogenes. The product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh Express Chopped Kit Chipotle Cheddar TOTAL NET WT. 11.3 oz (320G) SALAD TOPPINGS NET WT 9.1 oz (258Gg) DRESSING 2.3 fl. oz. (68 mL)/NET WT 2.2oz (62g) FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30604 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0760-2023·2023-05-03

    Patagonia Foods Blackberries Recalled for Possible Hepatitis A

    Patagonia Foods is recalling frozen blackberries (Lot 20422) distributed in six U.S. states due to possible Hepatitis A contamination. Consumers should not consume the product.

    Product
    Patagonia Foods 3610100 Blackberry IQF Product of Mexico Net Wt. 30 LBS. (13.61 kg) Production/Lot Code 20422 Distributed By: Patagonia Foods, LLC. San Luis Obispo, CA 93401 patagoniafoods.com
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1472-2023·2023-05-03

    Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings

    Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.

    Product
    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2023·2023-05-03

    Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings

    Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.

    Product
    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2023·2023-05-03

    Surgical forceps may fail to open during endoscopic procedures

    Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.

    Product
    FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0752-2023·2023-05-03

    Enriched Hot Dog Buns Recalled for Undeclared Sesame Allergen

    Our Family White Hot Dog Enriched Buns are being recalled due to undeclared sesame. The recall affects approximately 28,700 units distributed in Michigan, Ohio, Indiana, and Illinois, and poses a risk to consumers with sesame allergies.

    Product
    Our Family White Hot Dog Enriched Buns, 8 count 12oz. retail unit UPC 0-70253-75107-3
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1468-2023·2023-05-03

    Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility

    Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.

    Product
    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1436-2023·2023-05-03

    Sterile surgical C-section kit light handle covers recalled for separation risk

    ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2023·2023-05-03

    Biopsy forceps may fail to open when endoscope is bent

    Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.

    Product
    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0554-2023·2023-05-03

    Tadalafil Tablets Recalled Due to Manufacturing Practice Violations

    Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0569-2023·2023-05-03

    Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination

    Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.

    Product
    FYREMADEL — FYREMADEL (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0769-2023·2023-05-03

    Popped water lily seeds recalled due to undeclared milk

    Karma Spices and Trading Company is recalling Karma White Cheddar Cheese Popped Water Lily Seeds because the product contains undeclared milk. The recall affects 1,423 units distributed in Michigan and online.

    Product
    Karma White Cheddar Cheese Popped Water Lily Seeds packed in 1.5oz pouches UPC: 617201892589
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1421-2023·2023-05-03

    Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging

    Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.

    Product
    (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1467-2023·2023-05-03

    Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions

    Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.

    Product
    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2023·2023-05-03

    VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr

    Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.

    Product
    VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2023·2023-05-03

    Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

    ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2023·2023-05-03

    GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling

    Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.

    Product
    GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2023·2023-05-03

    Digital X-ray System Arm May Break, Posing Injury Risk

    FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.

    Product
    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0762-2023·2023-05-03

    Rajbhog Sweets Orange Jalebi Recalled Due to Undeclared Milk Allergen

    Rajbhog Sweets Orange Jalebi is recalled because the product label does not clearly disclose milk as an allergen, despite containing butter. Consumers with milk allergies who purchase this product face a health risk.

    Product
    Rajbhog Sweets Orange Jalebi Net Weight: 10 oz. UPC 3542647018 packaged in a plastic container and in bulk sold by weight
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0543-2023·2023-05-03

    Peritoneal dialysis solution recalled due to sterility assurance concerns

    Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2023·2023-05-03

    VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect

    Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.

    Product
    VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2023·2023-05-03

    Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect

    Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.

    Product
    Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
    Category
    Medical Device
    Distribution
    Distributed nationwide