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.

12101–12125 of 22152

  • HighFDA (Devices)·Z-1350-2024·2024-03-27

    Convatec EsteemBody Drainable Pouches Recalled for Filter Weld Defect

    ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistency in filter weld strength, affecting 6709 units distributed in the US and internationally.

    Product
    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect

    Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1075-2024·2024-03-27

    Dole Premium Kit Endless Summer Recalled for Potential Listeria Contamination

    Dole Fresh Vegetables Inc is recalling Dole Premium Kit Endless Summer salad kits due to potential Listeria monocytogenes contamination. Affected products have specific production codes dated February 2024.

    Product
    Dole Premium Kit Endless Summer UPC 71430010730
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-1081-2024·2024-03-27

    Bread Butter White Bread Recalled Due to Foreign Material Contamination

    Albertsons is recalling Signature Select, Athens, and Cal Pia brand Bread Butter White Bread due to possible metal and plastic shavings in the product. The recall affects approximately 13,550 units distributed in California and Nevada.

    Product
    Signature Select, Athens, and Cal Pia brand Bread Butter White Bread 22 oz. loaf
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1314-2024·2024-03-27

    Abbott Point of Care Control Device Recalled Due to Temperature Storage Failure

    Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.

    Product
    Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2024·2024-03-27

    Pregnancy Test Control Set Recalled for Temperature Excursion Risk

    McKesson recalls Abbott Rapid Dx pregnancy test control sets due to a refrigerator temperature excursion that could cause inaccurate or delayed test results.

    Product
    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1093-2024·2024-03-27

    La Fiesta ground cinnamon recalled due to elevated lead levels

    La Fiesta ground cinnamon (Canela Molida) is being recalled due to elevated lead levels. Affected products are 0.87oz bags with lot code 25033, distributed to retailers in California, Arizona, Washington, and Texas.

    Product
    La Fiesta, Canela Molida, Cinnamon Ground, 0.87oz (24.8g), UPC #032327000449, packed in cello bags
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1337-2024·2024-03-27

    Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function

    Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24172·2024-03-21

    BRS and BULin Liquid Fuel Bottles Recalled for Unsafe Closures

    BRS and BULin portable liquid fuel bottles sold on Amazon have non-child-resistant closures that violate federal safety law, posing risks of burns and poisoning to children. Consumers should stop using them and contact the seller for disposal and refund instructions.

    Product
    BRS and BULin Liquid Fuel Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24167·2024-03-21

    Fisher-Price Little People figures recalled due to detachable head choking hazard

    Fisher-Price is recalling Mickey and Friends figures sold since May 2023 because Donald and Daisy Duck heads can detach, posing a choking hazard. Three detachments were reported, including one found in a child's mouth, with no injuries.

    Product
    Fisher-Price Little People Mickey and Friends Figures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24166·2024-03-21

    Culture Kings Sneaker Basel Magnetic Levitation Displays Recalled for Laceration and Ingestion Hazards

    Culture Kings is recalling approximately 4,300 Sneaker Basel Magnetic Levitation Displays sold online from July 2020 through January 2023. The high-powered magnets can break and cause lacerations, or be swallowed and lodge in the digestive system, risking serious injury and death.

    Product
    Sneaker Basel Double Magnetic Levitation Displays
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24174·2024-03-21

    Ravin R500 Series Crossbows Recalled for Unexpected Discharge Injury Risk

    Ravin Crossbows LLC is recalling about 13,300 R500 series crossbows because they can unexpectedly discharge while being cocked or uncocked if not fully cocked, posing an injury hazard. The company has received one report of unexpected discharge but no injuries have been reported.

    Product
    Ravin R500 Model Crossbows
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24168·2024-03-21

    Crown Aruba IV Gas Boilers Recalled for Carbon Monoxide Hazard

    Crown Boiler Company is recalling about 1,100 Crown Aruba IV (AWR Series) gas-fired hot water boilers due to a blocked vent switch that can fail to shut down burners at high altitudes, allowing carbon monoxide to accumulate in homes.

    Product
    Crown Aruba IV (AWR Series) gas-fired hot water boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2024·2024-03-20

    Siemens Atellica IM Erythropoietin assay recalled for calibration bias error

    Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.

    Product
    Atellica IM Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2024·2024-03-20

    D-Clip Surgical Applier Recalled for Failure to Release During Surgery

    FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.

    Product
    D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0371-2024·2024-03-20

    FDA Recalls Rocuronium Bromide Injections Due to Improper Storage

    McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.

    Product
    ROCURONIUM BROMIDE — ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1297-2024·2024-03-20

    Hip prosthesis labeling guidance issue affects 34 units

    The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1060-2024·2024-03-20

    Jacksons Chicken Salad On A Croissant recalled for potential sesame cross contact

    Capitol Commissary LLC is recalling Jacksons Chicken Salad On A Croissant due to potential sesame cross contact. The product was distributed in seven western states.

    Product
    Jacksons Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 983642541561.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0382-2024·2024-03-20

    TRP Natural Eyes Pink Eye Relief Eye Drops Recalled for Sterility Concerns

    TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.

    Product
    TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1066-2024·2024-03-20

    KALO Carrot Cake mislabeled with Chocolate Cake ingredients, soy allergen undisclosed

    KALO Carrot Cake All Natural Gluten Free is mislabeled with Chocolate Cake ingredient information that omits soy, creating an allergen hazard for consumers with soy allergy.

    Product
    KALO Carrot Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1296-2024·2024-03-20

    Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type

    A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.

    Product
    SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0368-2024·2024-03-20

    Prescription drug Febuxostat recalled due to manufacturing contamination

    Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2024·2024-03-20

    D-Clip Surgical Applier Recalled Due to Failure to Release During Surgery

    A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.

    Product
    D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2024·2024-03-20

    EasyPoint Needle may detach inside patient during use

    Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.

    Product
    EasyPoint Needle, 25G x 5/8", REF: 82091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0376-2024·2024-03-20

    TRP Blur Relief Eye Drops Recalled Nationwide for Sterility Assurance Failure

    TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.

    Product
    TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
    Category
    Drug
    Distribution
    Distributed nationwide