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.

12201–12225 of 22209

  • HighFDA (Drugs)·D-0372-2024·2024-03-20

    Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation

    Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.

    Product
    Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
    Category
    Drug
    Distribution
    3 states
  • 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 (Food)·F-1068-2024·2024-03-20

    The Perfect Bite Co. frozen corn bites recalled due to listeria risk

    The Perfect Bite Co. is recalling Mexican Street Corn Bites due to possible Listeria monocytogenes contamination. The product was distributed in California and Washington.

    Product
    The Perfect Bite Co. Mexican Street Corn Bites 36 count Net Wt 29.9 oz (1lb 13.9oz) 847g UPC: 813341015752. Frozen product, packaged in a paper carton.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0370-2024·2024-03-20

    Potassium Chloride Injection Recalled Due to Pinhole Container Defects

    B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2024·2024-03-20

    ADVIA Centaur Erythropoietin Assay Affected by -35% Measurement Bias

    Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.

    Product
    ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0380-2024·2024-03-20

    TRP Natural Eyes Floaters Relief eye drops recalled due to sterility concerns

    Optikem International is recalling TRP Natural Eyes Floaters Relief eye drops nationwide due to lack of assurance of sterility in manufacturing. Affected bottles have lot numbers F404, F405, or F406.

    Product
    TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
    Category
    Drug
    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
  • HighFDA (Drugs)·D-0385-2024·2024-03-20

    Antibiotic Injection Recalled for Failed Stability Specification

    Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.

    Product
    TOBRAMYCIN — TOBRAMYCIN (TOBRAMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2024·2024-03-20

    TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance

    Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.

    Product
    TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2024·2024-03-20

    Shimadzu Trinias Digital Angiography System Recalled for Capacitor Defect

    Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.

    Product
    Shimadzu, Trinias, Digital Angiography System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1067-2024·2024-03-20

    KALO Chocolate Cake Recalled Due to Undeclared Soy Allergen

    KALO Chocolate Cake packages contain carrot cake with undeclared soy not listed on the label. Consumers with soy allergies are at risk of allergic reaction.

    Product
    KALO Chocolate 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
  • HighCPSC·24158·2024-03-14

    Honeywell System Sensor L-Series Fire Alarm Sounders and Strobes Recall

    Honeywell is recalling about 29,000 System Sensor L-Series low frequency fire alarm sounders and strobes because they can malfunction and fail to alert people to a fire. No injuries have been reported, but two units showed low or no sound output during installation.

    Product
    System Sensor L-series low frequency Sounders and Strobes for residential apartments and commercial buildings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24161·2024-03-14

    U.S. Boiler Company Recalls Gas-Fired Residential Boilers for Carbon Monoxide Hazard

    About 2,500 U.S. Boiler, New Yorker Boiler, Advantage, FORCE, and Archer brand gas-fired boilers are recalled because the blocked vent switch can fail at altitudes above 5,400 feet, allowing carbon monoxide to accumulate in homes. No injuries have been reported.

    Product
    U.S. Boiler, New Yorker Boiler, Advantage, FORCE and Archer brand gas-fired hot water residential boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24159·2024-03-14

    Insignia Air Fryers and Ovens Recalled for Fire and Burn Hazards

    Best Buy is recalling about 187,400 Insignia brand air fryers and air fryer ovens sold from November 2021 through November 2023 because the units can overheat, causing handles to melt, glass doors to shatter, and fires.

    Product
    Air Fryers and Air Fryer Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1023-2024·2024-03-13

    Frothy Monkey Spinach and Feta Croissants Recalled for Metal Fragments

    Bakery by Frothy Monkey is recalling Spinach & Feta Croissants sold in Tennessee and Alabama due to potential metal fragments. Consumers should not eat these croissants and should return them to the store.

    Product
    Frothy Monkey - Spinach & Feta Croissant - packaged and sold individually
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1262-2024·2024-03-13

    Howmedica X3 Triathlon CS Insert Recalled for Packaging Defects

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.

    Product
    X3 TRIATHLON CS INSERT NO 7 9 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2024·2024-03-13

    Aesculap Hasson Trocar Recall Due to Potentially Compromised Sterile Packaging

    Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.

    Product
    DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2024·2024-03-13

    Aesculap Hasson trocar recalled due to sterility packaging concerns

    Aesculap Inc has recalled Hasson trocar surgical instruments (18 units) because sterile blister packaging may be damaged and sterility compromised. The recall affects the U.S. (Kansas, New Jersey, New York) and Canada.

    Product
    DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1020-2024·2024-03-13

    Frothy Monkey Plain Croissants recalled for potential metal fragments

    Bakery by Frothy Monkey is recalling individually packaged Plain Croissants distributed in Tennessee and Alabama (Best By 01/31/2024) due to potential metal fragments.

    Product
    Frothy Monkey - Plain Croissant - packaged and sold individually
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1243-2024·2024-03-13

    Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility

    Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging

    Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2024·2024-03-13

    VITROS XT7600 System Aspiration Risk During Sample Processing

    Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.

    Product
    VITROS XT7600 Integrated System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1021-2024·2024-03-13

    Frothy Monkey Chocolate Croissants Recalled for Potential Metal Fragments

    Bakery by Frothy Monkey is recalling chocolate croissants due to the potential presence of metal fragments. The affected products were distributed in Tennessee and Alabama.

    Product
    Frothy Monkey - Chocolate Croissant - packaged and sold individually
    Category
    Food
    Distribution
    0 states