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.

11401–11425 of 22152

  • HighFDA (Devices)·Z-2054-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance

    Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2024·2024-05-29

    Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall

    Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.

    Product
    Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2024·2024-05-29

    Medical Device Mains Distribution Unit Recall Due to Fire Risk

    The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.

    Product
    Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2024·2024-05-29

    MRI Scanner Terminal Connection Fire and Smoke Risk

    Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.

    Product
    Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2024·2024-05-29

    FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration

    Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1251-2024·2024-05-29

    Geissler's Philadelphia Sushi Roll Recalled for Undeclared Milk Allergen

    Geissler's Supermarket is recalling Philadelphia Avo or Cucumber Classic Roll sushi due to undeclared milk allergen. Affected products were distributed in Connecticut and Massachusetts with sell-by dates 3/27/2024 and 3/28/2024.

    Product
    Geissler's Supermarket Philadelphia Avo or Cucumber Classic Roll (sushi roll) Ingredients read in part: "***INGREDIENTS: SMOKED SALMON, CREAM CHEESE, AVOCADO, CUCUMBER, RICE. NORI. WHITE STEAMEDRICE. VINEGAR. SUGAR. SALT. LEMON. MIRIN.WASABI. GINGER. WATER, SOYSAUCE (WHEAT, SOYB
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1263-2024·2024-05-29

    Aldi Macaroni Salad Mislabeled as Coleslaw; Contains Undeclared Wheat

    Aldi macaroni salad products are mislabeled with a coleslaw ingredient statement that does not declare wheat. Consumers with wheat allergies could experience serious allergic reactions if they consume the product.

    Product
    Product is MACARONI Salad, but the bottom container is mislabeled with the ingredients statement for COLESLAW. Product is refrigerated and packaged in a clear square container with 3 applied labels with a clear lid. Net Wt: 32oz. (2lbs) 907 g. There are 6 packages per case. Dist
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-2105-2024·2024-05-29

    Wolf Medical Syringes Recalled for Exceeding Approved Specifications

    Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.

    Product
    Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2024·2024-05-29

    Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard

    Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.

    Product
    SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1260-2024·2024-05-29

    Ground cinnamon recalled nationwide for elevated lead levels

    Supreme Tradition and Marcum brand ground cinnamon distributed to US retailers is being recalled due to elevated lead levels. Consumers should not use the affected products.

    Product
    Supreme Tradition brand and Marcum brand ground cinnamon. Packaged in 1.5 oz and 2.25 oz clear plastics jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2024·2024-05-29

    Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor

    Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing

    Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2024·2024-05-29

    GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance

    GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2024·2024-05-29

    GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance

    Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.

    Product
    Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1275-2024·2024-05-29

    YoCrunch vanilla yogurt recalled for undeclared wheat allergen

    DANONE US LLC is recalling YoCrunch Vanilla Lowfat Yogurt with M&Ms due to undeclared wheat. The product was distributed to one consignee in Florida and poses a risk to consumers with wheat allergies.

    Product
    YoCrunch¿ Vanilla Lowfat Yogurt with M&Ms 18 6oz cups per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2104-2024·2024-05-29

    Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance

    Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.

    Product
    Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2024·2024-05-29

    Medline non-sterile syringes recalled for out-of-specification piston configurations

    Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0506-2024·2024-05-29

    Haloperidol Decanoate Injections Recalled for Trace Water Contamination

    Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2024·2024-05-29

    Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2024·2024-05-29

    Thyroid Autoantibody Test System Recalled for Falsely Elevated Results

    Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2024·2024-05-29

    60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance

    Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.

    Product
    Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2024·2024-05-29

    Philips MRI System Recall: Loose Electrical Terminal May Cause Fire

    Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.

    Product
    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
    Category
    Medical Device
    Distribution
    Distributed nationwide