The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10801–10825 of 27089

  • HighFDA (Devices)·Z-2041-2024·2024-06-19

    MRI Systems Power Cable Terminal Block Fire Hazard Recall

    Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.

    Product
    MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-1360-2024·2024-06-19

    Grande Lactose SKU 30600 recalled for possible Salmonella contamination

    Grande Cheese Company is recalling Grande Lactose SKU 30600 due to possible Salmonella contamination across 24 U.S. states and three countries. No illnesses have been reported.

    Product
    Grande Lactose SKU 30600. Grade A. Refined Pasteurized. Net Wt 25 kg. Ingredients: Lactose Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI
    Category
    Food
    Distribution
    24 states
  • HighFDA (Drugs)·D-0549-2024·2024-06-19

    Phenazopyridine bottles recalled due to medication mix-up error

    RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.

    Product
    Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2031-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.

    Product
    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0546-2024·2024-06-19

    Zilretta Injectable Drug Recalled for Failed Stability Specifications

    Pacira Pharmaceuticals is recalling 43,768 kits of Zilretta injectable suspension due to failed stability specifications at 2–8°C storage for 12 months followed by 25°C for 6 weeks. No illnesses or injuries have been reported.

    Product
    ZILRETTA — ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2024·2024-06-19

    Aeos Robotic Digital Microscope recalled for safety mechanism failure

    Aesculap Inc is recalling Aeos Robotic Digital Microscope models with Product Code PV010 due to failure of the integrated safety mechanism. The robotic arm may drop more than 10 cm from its original position after the emergency stop button is pressed.

    Product
    Aeos Robotic Digital Microscope, Product Code: PV010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0545-2024·2024-06-19

    Prescription Drug Recall: Phenazopyridine Tablets Contain Wrong Medication

    Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.

    Product
    PHENAZOPYRIDINE HYDROCHLORIDE — PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2024·2024-06-19

    OMTech Desktop Laser Engraver recalled for missing safety interlocks

    Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.

    Product
    OMTech Desktop Laser Engraver
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2024·2024-06-19

    EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage

    Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.

    Product
    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2024·2024-06-19

    Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content

    B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.

    Product
    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2024·2024-06-19

    EsoFLIP 30mm Balloon Dilation Catheter Recalled for Measurement Inaccuracy

    Covidien is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal measurements, potentially leading to patient harm.

    Product
    EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2024·2024-06-19

    VITROS Immunodiagnostic Calibrators Recalled for Potential Accuracy Bias

    Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2024·2024-06-19

    CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall

    Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.

    Product
    CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2024·2024-06-19

    NEOMED Pharmacy Syringes recalled due to missing expiration dates

    Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2036-2024·2024-06-19

    NEOMED nonsterile pharmacy syringes recalled for missing expiration dates on labels

    Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2024·2024-06-19

    Darby Dental Prophylaxis Paste Mislabeled with Incorrect Part Number

    Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.

    Product
    Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0550-2024·2024-06-19

    Asmanex (Mometasone Furoate) Recalled Due to Defective Container

    Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0552-2024·2024-06-19

    Asmanex Twisthaler inhalation powder recalled due to defective container

    Organon LLC is recalling Asmanex Twisthaler (mometasone furoate) inhalation powder nationwide due to defective containers. Affected lot #Y000085 expires April 25, 2025.

    Product
    Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.

    Product
    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2024·2024-06-19

    Medical device nerve block needles incorrectly labeled as DEHP-free

    Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0551-2024·2024-06-19

    ASMANEX Inhalation Powder Recalled Due to Defective Container

    Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2024·2024-06-19

    Strep A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.

    Product
    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2024·2024-06-19

    NEOMED Oral Syringes Recalled Over Missing Expiration Dates on Labels

    Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1359-2024·2024-06-19

    TriyBrewed Coffee Concentrate Recalled for Missing Ingredient and Nutrition Labels

    Waco Bottling LLC is recalling TriyBrewed Coffee Concentrate 6oz bottles due to missing ingredient statement and nutrition label. Consumers cannot verify product contents or nutritional information.

    Product
    TriyBrewed Coffee Concentrate 6oz/177ml, amber glass bottle, 6pcs to case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1309-2024·2024-06-12

    Food Stabilizer and Emulsifier System Recalled for Potential Salmonella

    Danisco USA Inc. is recalling Grindsted Hi-Dress CDS 1880 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed to facilities across multiple US states, Canada, and Mexico.

    Product
    Grindsted Hi-Dress CDS 1880 Stabilizer and Emulsifier System, 22.68 kg / 50 lb bag
    Category
    Food
    Distribution
    24 states