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.

7801–7825 of 88183

  • HighFDA (Devices)·Z-1895-2025·2025-06-11

    Signature Laparoscopic Debakey Grasper Instruments Recalled for Insulation Defect

    Silex Medical is recalling 8 units of Signature Laparoscopic Debakey Grasper instruments (Model 5862100) due to incomplete insulation on the shaft near the rotator wheel, which could expose the user or patient to electrical contact.

    Product
    Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2025·2025-06-11

    Signature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall

    Silex Medical recalls the Signature Laparoscopic Sharp Tooth Grasper due to incomplete insulation on the shaft near the rotator wheel, which creates an electrical hazard during use.

    Product
    Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2025·2025-06-11

    Olympus EVIS EXERA III Duodenovideoscope TJF-Q190V Contamination Risk

    Olympus is recalling the EVIS EXERA III Duodenovideoscope Model TJF-Q190V due to post-market data showing higher microbial contamination when manual cleaning is delayed beyond one hour after patient use.

    Product
    Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2025·2025-06-11

    Signature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall

    Silex Medical is recalling 6 units of the Signature Laparoscopic Bullet Tip Grasper with Rotating Shaft due to incomplete insulation on the shaft near the rotator wheel, which could expose users to electrical hazards.

    Product
    Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2025·2025-06-11

    Pre-filled Water Syringe recalled for improper use contamination

    Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.

    Product
    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1892-2025·2025-06-11

    BX2 Needle Guide may develop transducer cover breach during attachment

    Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.

    Product
    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1905-2025·2025-06-11

    MIRA Surgical System software update recall for motion display issue

    Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.

    Product
    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1890-2025·2025-06-11

    FoundationOne Companion Diagnostic contains incorrect negative claims

    Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0454-2025·2025-06-11

    Indomethacin Extended-Release Capsules recalled for cGMP deviations

    Amerisource Health Services LLC is recalling Indomethacin Extended-Release Capsules 75 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 21 cartons distributed nationwide.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1878-2025·2025-06-11

    Lazervida 10W Diode Laser Engraver Does Not Meet Federal Safety Standards

    Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.

    Product
    Lazervida 10W diode laser cutter and engraver with Lazervida shield.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0457-2025·2025-06-11

    Lacosamide Oral Solution recalled for defective leaking containers

    Apotex Corp. is recalling Lacosamide Oral Solution because certain bottles may leak when stored horizontally. Patients taking this seizure medication should contact their pharmacy or healthcare provider.

    Product
    Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2025·2025-06-11

    Beckman Coulter Sample Probe Manufacturing Defect Recall

    Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2025·2025-06-11

    FoundationOne Companion Diagnostic F1CDx Incorrect Claim Display

    Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2025·2025-06-11

    DxI 9000 Access Immunoassay Analyzer Software Update Error Codes

    Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.20 because the update introduces error codes that prevent assays from being performed and may delay result generation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0012-2025·2025-06-11

    Dr. Pepper Zero Sugar cans mislabeled as zero sugar contain full sugar

    Pepsi Beverages Company is recalling Dr. Pepper Zero Sugar aluminum cans because the product contains full sugar despite being labeled as zero sugar. Affected 12 and 24 pack cases were distributed to Florida, Georgia, and South Carolina.

    Product
    Dr. Pepper, ZERO SUGAR, 12 FL OZ (355 mL) ALUMINUM CAN packaged and sold as 12 packs and 24 packs cartons cases. PRODUCED UNDER THE AUTHORITY OF CB Manufacturing Company, Inc., 5829 Pepsi Pl., Jacksonville, Florida, United States of America, 32216 - 904-443-0763 who is licensed…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0458-2025·2025-06-11

    Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content

    Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.

    Product
    HAND SANITIZER — HAND SANITIZER (ETHYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0839-2025·2025-06-11

    Sysco Classic and Bay Valley Foods Thank You Chocolate Pudding Recall

    Treehouse Foods is recalling Sysco Classic and Bay Valley Foods Thank You chocolate pudding in 7lb cans due to post-process container damage that could allow microbial growth and cause containers to swell or explode.

    Product
    Sysco Classic chocolate pudding, 7lb #10 metal can, UPC 074865103817, 6 cans per case. Bay Valley Foods Thank You chocolate pudding, 7lb #10 metal can, UPC 041820062205 , 6 cans per case.
    Category
    Food
    Distribution
    15 states
  • LowFDA (Food)·H-0009-2025·2025-06-11

    Best Taste Brand Salted Shrimp Paste Sauce Recalled for Undeclared FD&C Red #3

    Best Taste Brand Salted Shrimp Paste Sauce (12 oz) is recalled because it contains undeclared FD&C Red #3, a food coloring that is not listed on the label.

    Product
    Best Taste Brand Salted Shrimp Paste Sauce; ING: Shrimp, sugar, salt; COUNTRY FAVOR, INC; PRODUCT OF VIETNAM; Net Weight: 12 oz (350 g)
    Category
    Food
    Distribution
    19 states
  • LowFDA (Food)·F-0840-2025·2025-06-11

    Nordic Naturals Zero Sugar Kids Multivitamin Gummies Recall

    Nordic Naturals is recalling Zero Sugar Kids Multivitamin Supplement gummies due to product mislabeling. Consumers should stop using the product and contact the manufacturer with questions.

    Product
    Nordic Naturals Zero Sugar Kids Multivitamin Supplement - Gummies (120 gummies/bottle); 12 bottles/case
    Category
    Consumer Product
    Distribution
    20 states
  • SevereFDA (Food)·F-0811-2025·2025-06-04

    Mauna Loa Dark Chocolate Covered Macadamias Recalled for Undeclared Nuts

    Hawaiian Host Candies is recalling Mauna Loa Dark Chocolate Covered Macadamias due to undeclared almond and cashew. The product label does not list these allergens and may pose a risk to consumers with tree nut allergies.

    Product
    Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic flexible pouch. Dist. By Mauna Loa Macadamia Nut Corp. Kea au, Hawaii 96749, USA. Label declares Contains: Tree Nuts (Macadamia), Milk and Soy. Each master case…
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0449-2025·2025-06-04

    Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2025·2025-06-04

    Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit

    Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2025·2025-06-04

    Carvedilol Tablets Recalled Due to N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide