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.

6051–6075 of 52958

  • HighFDA (Devices)·Z-0670-2025·2024-12-18

    BD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect

    An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.

    Product
    BD Pyxis MedStation ES, REF: 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2025·2024-12-18

    MICRO-X Rover Mobile X-ray System Exposure Timing Defect Recalled

    Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2025·2024-12-18

    Levothyroxine Sodium Tablets recalled nationwide for potency failures

    Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2025·2024-12-18

    FDA Recalls DKS Disposable Kerrison System Surgical Instruments

    Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.

    Product
    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Sma
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Drugs)·D-0131-2025·2024-12-18

    Levothyroxine Sodium 100 mcg Tablets Recalled for Potency Deviations Nationwide

    Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V939000·2024-12-18

    2024 Polestar 2 driver-side air bag module improper deployment

    Polestar is recalling certain 2024 Polestar 2 vehicles because clamps on the driver's side air bag module may be improperly crimped, causing the air bag to deploy improperly and reducing crash protection.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V938000·2024-12-18

    Volvo Recalls 2023-2024 C40 Vehicles for Air Bag Clamp Defect

    Volvo is recalling 2023-2024 C40 vehicles because improperly crimped clamps may cause the driver's air bag to deploy improperly, increasing injury risk.

    Product
    VOLVO — VOLVO C40BEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0258-2025·2024-12-18

    Homemade corn salsa recalled for improper pH level

    L & L Homemade Corn Salsa in 16 oz glass jars was voluntarily recalled because the product had a pH of 4.7, identified as unsafe. The recall affected 192 jars distributed in Illinois and Wisconsin.

    Product
    L & L Homemade Corn Salsa in 16 oz Glass jar. W1520 Starr Road, Granton, WI 54436
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0119-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg due to potency failures in some tablets being stronger or weaker than specified. The recall affects 118,324 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2025·2024-12-18

    Medical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results

    Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.

    Product
    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0126-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0134-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Nationwide for Potency Variance

    Mylan Institutional recalls 1,133 cartons of Levothyroxine Sodium Tablets (137 mcg) nationwide. Three lots contain subpotent and superpotent tablets.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0281-2025·2024-12-18

    7-Eleven Chicken Salad Sandwiches Mislabeled; Contain Tuna Instead

    7-Eleven Chicken Salad Sandwiches (UPC 7 63913-79486 1) are mislabeled and actually contain tuna salad. The product poses a risk to consumers with tuna allergies.

    Product
    7-Eleven Chicken Salad Sandwich, UPC 7 63913-79486 1. Net Wt. 7.0 oz (198g), Keep Refrigerated. Mfg By: Supermom's St. Paul Park, MN 55071
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0263-2025·2024-12-18

    Sweet Sam's Chocolate Chunk Brownies Recalled for Undeclared Soy

    Sweet Sam's Baking Company is recalling 10,164 units of Individually Wrapped Chocolate Chunk Brownies due to undeclared soy lecithin, a major allergen. Consumers with soy allergies face a potential health risk from this labeling oversight.

    Product
    Sweet Sam's Individually Wrapped Chocolate Chunk Brownie 12- pack Individually Wrapped 3.2 oz Chocolate Chunk Brownies
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0130-2025·2024-12-18

    Prescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2025·2024-12-18

    Dabigatran Etexilate 75 mg capsules recalled for N-nitroso impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V940000·2024-12-18

    2025 Polestar 3 Vehicles High to Low Voltage Converter Damage Recall

    Polestar is recalling certain 2025 Polestar 3 hybrid electric vehicles due to potential damage to the High to Low Voltage Converter Module, which may cause sudden loss of drive power and increase crash risk.

    Product
    POLESTAR — POLESTAR POLESTAR 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0269-2025·2024-12-18

    Cucumber Chunk & Tomato Wedge Recalled for Salmonella Risk

    Sysco Corporation is recalling Cucumber Chunk & Tomato Wedge products due to potential Salmonella contamination in cucumbers. Products were distributed in Iowa, Minnesota, South Dakota, North Dakota, Wisconsin, and Canada.

    Product
    Cucumber Chunk & Tomato Wedge Item 11835. 2/2.5 lb. Keep Refrigerated
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0135-2025·2024-12-18

    FDA Recalls Levothyroxine Sodium Tablets for Potency Variation

    Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2025·2024-12-18

    Hermes Medical Imaging Software May Cause Incorrect Image Reconstruction

    Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.

    Product
    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Drugs)·D-0118-2025·2024-12-18

    Drug Recall: Levothyroxine Sodium Tablets Affected by Potency Failures

    Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2025·2024-12-18

    MICRO-X Rover Mobile X-ray System delivers lower-than-set radiation doses

    Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2025·2024-12-18

    Levothyroxine sodium tablets recalled for potency failures nationwide

    Viatris Inc is recalling Levothyroxine Sodium Tablets USP 75 mcg due to potency failures affecting approximately 63,077 bottles distributed nationwide in the US and Puerto Rico. Some tablets are superpotent while others are subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2025·2024-12-18

    Automated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors

    The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.

    Product
    BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide