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.

10901–10925 of 27206

  • SevereFDA (Food)·F-1367-2024·2024-06-19

    FDA Recalls Grande Ultra Whey Protein Isolate for Possible Salmonella

    GRANDE CHEESE COMPANY is recalling Grande Ultra 9100 Functional Whey Protein Isolate (SKU 32131) due to possible Salmonella contamination. The recall affects 1.7 million pounds distributed to 24 U.S. states and international markets.

    Product
    Grande Ultra 9100 Functional Whey Protein Isolate. SKU 32131. 90% Protein. Grade A. Pasteurized. Net Wt 20 kg. Ingredients: Whey Protein Isolate Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Food)·F-1344-2024·2024-06-19

    Claw Crab Meat Recall Due to Listeria Contamination

    Irvington Seafood is recalling claw crab meat due to Listeria monocytogenes contamination found during product testing. The affected product was distributed in Mississippi and Alabama.

    Product
    Irvington Seafood Claw Crab Meat packaged in 1lb plastic cups. 40 lb cases
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1365-2024·2024-06-19

    Grande Bravo Whey Protein Recalled Due to Salmonella Contamination

    Grande Bravo 550 Functional Whey Protein is being recalled due to possible Salmonella contamination. Affected batches ANV508-1 and ANV508-3 were distributed across 24 U.S. states and internationally.

    Product
    Grande Bravo 550 Functional Whey Protein SKU 32105. 34% Protein. Grade A. Pasteurized. Net Wt 50 lbs. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Food)·F-1368-2024·2024-06-19

    Whey Protein Isolate Recalled for Possible Salmonella Contamination

    Grande Cheese Company is recalling Grande Ultra 8000 Nutritional Whey Protein Isolate due to possible Salmonella contamination. The affected batches include AOE813-1 through AOE813-4 and AOF840-1 through AOF840-4.

    Product
    Grande Ultra 8000 Nutritional Whey Protein Isolate. SKU 32200. 80% Protein Dry Basis. Grade A. Pasteurized. Net Wt 20 kg. Ingredients: Whey Protein Concentrate Contains Milk. Grande Custom Ingredients Group, 250 Camelot Drive, Fond du Lac, WI
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Food)·F-1341-2024·2024-06-19

    Irvington Seafood Jumbo Crab Meat recalled for Listeria contamination

    Irvington Seafood is recalling Jumbo Crab Meat due to Listeria monocytogenes found during product testing. Affected packages distributed in Mississippi and Alabama should not be consumed.

    Product
    Irvington Seafood Jumbo Crab Meat packaged in 1 lb plastic cups. 40 lbs cases
    Category
    Food
    Distribution
    2 states
  • 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-2133-2024·2024-06-19

    Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue

    B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.

    Product
    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2024·2024-06-19

    Cardiac SPECT System Recalled for Defective Service Handle Fastening

    GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.

    Product
    MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2135-2024·2024-06-19

    CORI Surgical System Software Error Causes Tracking Array Flickering

    The CORI Starter Kit surgical system may experience display flickering from a software tracking error, potentially causing surgical delays during orthopedic procedures.

    Product
    CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (Food)·F-1358-2024·2024-06-19

    Jamai Bou Chanachur Snack Mix Recalled for Undeclared Peanuts

    Jamai Bou CHADNI HOT MIX CHANACHUR snack is being recalled because peanuts are present but not declared on the label. This poses a serious risk to consumers with peanut allergies.

    Product
    Jamai Bou CHADNI HOT MIX CHANACHUR, 300 g (10.5 oz) bag, UPC 8 904293 104129, 30 bags per wholesale case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0547-2024·2024-06-19

    Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk

    Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.

    Product
    Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA is recalling 102,500 units of IMCO Strep A Rapid Test Kits due to unauthorized distribution for at-home, over-the-counter, and direct-to-consumer use.

    Product
    Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
    Category
    Medical Device
    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 (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-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-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-2034-2024·2024-06-19

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

    Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.

    Product
    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2024·2024-06-19

    Fresenius AquaA hemodialysis water purification device pressure control malfunction

    Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.

    Product
    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
    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-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 (Drugs)·D-0548-2024·2024-06-19

    FDA Recalls Eye Suspension Medication for Lack of Sterility Assurance

    Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.

    Product
    Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2024·2024-06-19

    Stimuplex A Injection Needles Recalled for DEHP Mislabeling

    B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
    Category
    Medical Device
    Distribution
    Distributed nationwide