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.

23251–23275 of 88183

  • HighFDA (Devices)·Z-1444-2022·2022-07-27

    Aesculap S4 Cervical Cross Connector Spinal Implant System Recalled for Clamping Failure

    Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector (product code SWT113T) used in spinal fusion surgery. The connectors may not clamp properly onto rods, potentially causing movement and wear particles.

    Product
    AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2022·2022-07-27

    Spinal fixation removal key fracture risk under misuse conditions

    The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2022·2022-07-27

    Stryker Triton Canister Scanning Labels Recalled Due to Color Variance

    Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.

    Product
    Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1281-2022·2022-07-27

    Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.

    Product
    Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1449-2022·2022-07-27

    Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Allergen

    Chuckanut Bay Foods LLC is recalling Sharis Strawberry Cheesecake Bites (Lot Code 2C159A2) due to undeclared soy lecithin. The label lists sunflower lecithin when the product actually contains soy lecithin, posing a risk to consumers with soy allergies.

    Product
    Item 81109-12, Chuckanut Bay Sharis Strawberry Cheesecake Bites. Perishable - Keep Refrigerated. There are 9 pieces per pack and 12 packs per case. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR, PASTEURIZED CULTURED MILK INGREDIENTS: CANE SUGAR…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1436-2022·2022-07-27

    BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage

    Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay treatment and expose patients to biohazardous material.

    Product
    BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1506-2022·2022-07-27

    Chicken Breading Recalled Due to Undeclared Wheat Allergen

    Belmatt Inc is recalling Targil's St. Amand's Chicken Breading due to undeclared wheat. The product was distributed in Louisiana and poses a health risk to those with wheat allergies or celiac disease.

    Product
    Targil's St. Amand's Chicken Breading packaged in 25lb boxes
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1532-2022·2022-07-27

    Lemon Muffins Recalled Due to Plastic Material Contamination

    Portland Specialty Baking is recalling Lemon Muffins due to plastic material contamination. The affected product was distributed in California, Idaho, and Oregon.

    Product
    Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and there are 6 trays per master case. PSB (Portland Specialty Baking) master case label is read in parts: "***PSB***LEMON MUFFINS *** 802387***6/36…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1267-2022·2022-07-27

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.

    Product
    Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1454-2022·2022-07-27

    Carmel Classic Truffle Recalled for Undeclared Tree Nuts

    Queen Bee Gardens recalled Carmel Classic Truffle candies because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). Consumers with tree nut allergies should not consume this product.

    Product
    Carmel Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 110005 4. Ingredients: Milk chocolate, honey, ivory chocolate, butter (pasteurized cream & salt), cream, non-fat dry milk, caramel flavor, whey, agar, algin & lecithin.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2022·2022-07-27

    Truffle Gift Box Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Truffle Gift Boxes due to undeclared tree nuts that may pose a hazard to allergic consumers. Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide online.

    Product
    Truffle Gift Box PLU Code: 788394 17655 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1252-2022·2022-07-27

    Fentanyl Citrate Injection Recall Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Fentanyl Citrate Injection nationwide due to lack of assurance of sterility. Approximately 9,410 bags distributed to healthcare facilities are affected.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1250-2022·2022-07-27

    Epinephrine Injection Recalled Due to Sterility Assurance Failure

    Nephron is recalling epinephrine injection syringes nationwide due to lack of sterility assurance. No illnesses have been reported to date.

    Product
    EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1479-2022·2022-07-27

    Honey Caramels Pecan Pearl Recalled for Undeclared Tree Nuts

    Queen Bee Gardens recalls Honey Caramels Pecan Pearl due to potential undeclared tree nuts including almonds, coconut, macadamia, and walnuts that may pose a risk to consumers with allergies.

    Product
    Honey Caramels Pecan Pearl. Net wt. 5.87 oz. PLU Code: 788394 12804 2. Ingredients: Honey, butter (pasteurized cream & salt), cream, grade A fancy pecans, nonfat dry milk, whey, pure vanilla, lecithin, algin & agar.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1262-2022·2022-07-27

    Labetalol Injection Recalled Nationwide Over Sterility Assurance Defect

    Nephron Sterile Compounding Center is recalling 184,370 syringes of Labetalol HCl Injection nationwide due to lack of assurance of sterility. Patients using the affected lots should contact their healthcare provider.

    Product
    Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1503-2022·2022-07-27

    Chicken Breading Recalled Due to Undeclared Wheat Allergen

    Belmatt Inc is recalling Targil's Hot Tails Louisiana Crawfish House Chicken Breading (5,083 pounds, Lot 0206102202) due to undeclared wheat. The product was distributed in Louisiana and poses a risk to consumers with wheat allergies.

    Product
    Targil's Hot Tails Louisiana Crawfish House Chicken Breading packaged in 25lb boxes
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1248-2022·2022-07-27

    Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.

    Product
    0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1278-2022·2022-07-27

    Compounded Sterile Injectable Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling 2210 syringes of a three-drug compounded injectable due to lack of assurance of sterility.

    Product
    Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2022·2022-07-27

    BD Connecta White 360 Infusion Connector Recalled for Potential Leakage

    Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.

    Product
    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1446-2022·2022-07-27

    Chuckanut Bay Lemon Cheesecake Bites Recalled for Undeclared Soy Lecithin

    Chuckanut Bay Foods is recalling Lemon Cheesecake Bites because the label declares Sunflower Lecithin when the product actually contains Soy Lecithin. Consumers with soy allergies may unknowingly consume these products and experience allergic reactions.

    Product
    Item 39432-12, Chuckanut Bay DIPPED CHEESECAKE BITES Lemon. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net Wt. 3.2 oz. UPC 6 03812 39432 1. Item 32032-1, Chuckanut Bay Lemon Cheesecake Bites (Dark Compound) BULK. There are 14 pieces…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1505-2022·2022-07-27

    Flavor Flour product recalled for undeclared wheat allergen

    Belmatt Inc is recalling Targil's Parker's Flavor Flour because the product contains wheat that was not declared on the label. Wheat is a major allergen that must be labeled for consumer safety.

    Product
    Targil's Parker's Flavor Flour packaged in 25lb boxes
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1459-2022·2022-07-27

    German Chocolate Truffle Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling German Chocolate Truffles because they may contain undeclared tree nuts. The recall affects products sold in Colorado, New Mexico, Wyoming, and through nationwide internet sales.

    Product
    German Chocolate Truffle. Net Wt. 1.4 oz. PLU Code: 788394 11058 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1489-2022·2022-07-27

    Dark Chocolate Pecan Recalled for Undeclared Tree Nuts

    Queen Bee Gardens recalls Honeymoons Dark Chocolate Pecan for undeclared tree nuts including almonds, coconut, macadamia, and walnuts. The product was distributed through retail locations in CO, NM, and WY, and nationwide via internet sales.

    Product
    Honeymoons Dark Chocolate Pecan. PLU Code: 788394 14720 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1504-2022·2022-07-27

    Food product recall: Undeclared wheat in Targil's Hot Tails Hush Puppies

    Belmatt Inc recalled Targil's Hot Tails Louisiana Crawfish House Hush Puppies in 25lb boxes due to undeclared wheat. The product poses a risk to consumers with wheat allergies.

    Product
    Targil's Hot Tails Louisiana Crawfish House Hush Puppy packaged in 25lb boxes
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1449-2022·2022-07-27

    Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue

    Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.

    Product
    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
    Category
    Medical Device
    Distribution
    14 states