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.

13751–13775 of 53086

  • HighFDA (Drugs)·D-0487-2023·2023-04-05

    Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination

    Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.

    Product
    Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0669-2023·2023-04-05

    Perilla Leaves in Soybean Paste recalled for undeclared allergens

    Lemonland Food Corp recalls Perilla Leaves in Soybean Paste for undeclared soybean, wheat, fish, and shrimp allergens. Consumers with these allergies should avoid the product.

    Product
    Perilla Leaves in Soybean Paste distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1290-2023·2023-04-05

    GaGa Pro Class IV Laser Projectors Recalled for FDA Compliance Failure

    GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.

    Product
    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2023·2023-04-05

    Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks

    Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.

    Product
    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0534-2023·2023-04-05

    Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity

    Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2023·2023-04-05

    Surgical Robot Instrument Carriage Loose Due to Manufacturing Defect

    Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.

    Product
    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1316-2023·2023-04-05

    Baxter Automated Peritoneal Dialysis System Electrical Safety Testing Failure

    Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.

    Product
    Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0661-2023·2023-04-05

    Seasoned Nut Recalled for Undeclared Peanut and Walnut Allergens

    Lemonland Food Corp recalled seasoned nut products for undeclared peanut and walnut allergens. Consumers with allergies to these nuts should not consume affected products sold in Washington between February 16-23, 2023.

    Product
    Seasoned Nut distributed in un-labeled plastic containers 6oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0683-2023·2023-04-05

    Seasoned Seaweed Recalled for Undeclared Sesame and Wheat Allergens

    Lemonland Food Corp is recalling Seasoned Seaweed distributed in Washington due to undeclared sesame seeds and wheat. Consumers with these allergies should not consume the product.

    Product
    Seasoned Seaweed distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0678-2023·2023-04-05

    Seasoned Lotus Root Recalled for Undeclared Soybean and Wheat

    Lemonland Food Corp recalled Seasoned Lotus Root for containing undeclared soybean and wheat allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Seasoned Lotus Root distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0479-2023·2023-04-05

    Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

    Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

    Product
    Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0658-2023·2023-04-05

    Stir-Fried Fish Cake Recalled Due to Undeclared Allergens

    Lemonland Food Corp recalled stir-fried fish cake due to undeclared soybean, wheat, fish, and sesame allergens. The affected products were distributed in Washington from February 16 to 23, 2023.

    Product
    Stir-Fried Fish Cake distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1311-2023·2023-04-05

    Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

    Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0675-2023·2023-04-05

    Seasoned Dried Pollack Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Seasoned Dried Pollack distributed in Washington for undeclared Fish, Wheat, and Soybean allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Dried Pollack distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0670-2023·2023-04-05

    Seasoned Peanut Recalled Due to Undeclared Peanut, Soybean, Wheat, and Sesame

    Lemonland Food Corp is recalling Seasoned Peanut distributed in Washington due to undeclared allergens including peanut, soybean, wheat, and sesame seeds. Containers were labeled at H-mart, G-mart, and M2M retail stores.

    Product
    Seasoned Peanut distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1304-2023·2023-04-05

    ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.

    Product
    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0680-2023·2023-04-05

    Stir-Fried Dried Squid Recalled for Undeclared Milk, Wheat, and Soybean

    Lemonland Food Corp recalled Stir-Fried Dried Squid distributed in Washington for undeclared Milk, Wheat, and Soybean allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Stir-Fried Dried Squid distributed in un-labeled plastic containers 6oz., 8oz., and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1309-2023·2023-04-05

    Leksell Stereotactic System Recall: Incorrect Instructions Distributed with Devices

    Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.

    Product
    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2023·2023-04-05

    CRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples

    Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.

    Product
    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0674-2023·2023-04-05

    Seasoned Radish Sliced Recalled for Undeclared Fish, Shrimp, and Sesame

    Lemonland Food Corp is recalling Seasoned Radish Sliced products distributed in Washington due to undeclared Fish, Crustacean, and Sesame allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Radish Sliced distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0673-2023·2023-04-05

    Wild Leek Recalled for Undeclared Soy, Wheat, and Fish Allergens

    Lemonland Food Corp is recalling Wild Leek sold in Washington due to undeclared allergens: soybean, wheat, and fish (anchovy). Consumers with allergies to these ingredients should avoid this product.

    Product
    Wild Leek distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1302-2023·2023-04-05

    Chest Drain Valve Recalled for Insufficient Safety Instructions

    The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2023·2023-04-05

    Irvine Scientific embryo culture oil recalled due to detected toxicity

    Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.

    Product
    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-0655-2023·2023-04-05

    Seasoned Pollack Roe Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Seasoned Pollack Roe due to undeclared fish allergen. The product was distributed in Washington from February 16-23, 2023.

    Product
    Seasoned Pollack Roe distributed in un-labeled plastic containers 6oz and 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state