The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16601–16625 of 53124

  • 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
  • HighFDA (Food)·F-1493-2022·2022-07-27

    Toffee Bites Patties Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Toffee Bites Patties Gift Boxes due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts) that may pose a risk to people with nut allergies.

    Product
    Toffee Bites Patties Gift Box. Net wt. 3 oz. PLU Code: 788394 17777 4.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1465-2022·2022-07-27

    Bee Joyful Bars Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Bee Joyful Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product poses a health risk to consumers with tree nut allergies.

    Product
    Bee Joyful Bars. Net wt. 1.5 oz. PLU Code: 788394 18565 6. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], sunflower lecithin & pure vanilla), Honey, Butter (Pasteurized cream & Salt), Cream, Coconut…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1433-2022·2022-07-27

    Revie Superfoods Heart Beet Smoothie Mix Recalled for Potential Norovirus

    Revive Organics is recalling Revie Superfoods Heart Beet 206g Ready-to-Blend smoothie mix due to potential norovirus contamination in frozen raspberries used in the product. Consumers should not consume affected lots.

    Product
    Revie Superfoods Heart Beet 206g Ready-to-Blend Cardamom + Beet Smoothie Made in Canada UPC 8 53267 00112 5 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, Canada
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1472-2022·2022-07-27

    Honey Caramels Blue Raspberry Recalled for Undeclared Tree Nuts

    Queen Bee Gardens is recalling Honey Caramels Blue Raspberry due to undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). The product poses a serious risk to consumers with tree nut allergies.

    Product
    Honey Caramels Blue Raspberry. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz. bag: 788394 12675 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2022·2022-07-27

    Hill-Rom Centrella Pro+ surface mattress microclimate management feature failure

    Baxter Healthcare is recalling Hill-Rom Centrella Pro+ surface mattresses due to a potential Microclimate Management feature failure that may increase the risk of pressure ulcer development.

    Product
    Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1277-2022·2022-07-27

    Rocuronium Bromide Pre-Filled Syringes Recalled for Sterility Assurance

    Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection syringes nationwide due to lack of assurance of sterility. Approximately 6,340 syringes from lot RC2003B (expiration August 28, 2022) are affected.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 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: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1448-2022·2022-07-27

    Chuckanut Bay cheesecake bites recalled for undeclared soy lecithin

    Chuckanut Bay Foods is recalling Dipped Cheesecake Bites (Berry) due to undeclared soy lecithin. The label incorrectly lists sunflower lecithin, potentially endangering consumers with soy allergies.

    Product
    Item 39421-12, Chuckanut Bay DIPPED CHEESECAKE BITES Berry. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per case. Net wt. 3.2 oz per package. UPC 6 03812 39421 5. The label is read in parts: "***INGREDIENTS: CREAM CHEESE***, CANE SUGAR…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1274-2022·2022-07-27

    Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/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: 69374-955-10
    Category
    Drug
    Distribution
    Distributed nationwide