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.

13526–13550 of 27206

  • HighFDA (Devices)·Z-0566-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination

    CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0575-2024·2023-12-27

    Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy

    Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.

    Product
    Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0585-2024·2023-12-27

    Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure

    Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.

    Product
    Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0606-2024·2023-12-27

    Frozen Spinach Artichoke Pizzas Recalled for Undeclared Wheat

    Shakespeare's Pizza recalls 7,103 units of frozen Spinach Artichoke Pizza sold in Missouri and Kansas due to undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Shakespeare's Pizza, Spinach Artichoke Pizza, 25 oz, Keep Frozen; UPC 686 148 000 043; pack size 18 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0570-2024·2023-12-27

    Biomet Recalls Hip Implant Adapter Due to Wrong Specification in Packaging

    Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0152-2024·2023-12-27

    Selenium Sulfide 2.25% Shampoo Recalled Due to Unsupported Expiry Date

    Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.

    Product
    Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0565-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination

    CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0558-2024·2023-12-27

    Philips Allura Medical Imaging Systems Ceiling Mount May Fall

    Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.

    Product
    Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2024·2023-12-27

    Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results

    Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.

    Product
    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2024·2023-12-27

    Nystatin bulk powder recall due to incorrect assay strength label

    Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.

    Product
    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0567-2024·2023-12-27

    AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On

    AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.

    Product
    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2024·2023-12-27

    Exactech Novation Hip System Recalled for Vacuum Seal Loss

    Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.

    Product
    Exactech Novation Hip System, Catalog Numbers: 134-36-45
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0559-2024·2023-12-27

    Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall

    Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.

    Product
    Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2024·2023-12-27

    Exactech Equinoxe Shoulder System recalled for vacuum loss in bags

    Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.

    Product
    Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0576-2024·2023-12-27

    Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation

    Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.

    Product
    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment suppor
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0609-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk

    Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2024·2023-12-27

    Injection needles and cannulas recalled for cleaning process efficacy issues

    Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.

    Product
    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0604-2024·2023-12-27

    Shakespeare's Pizza frozen pizza recalled for undeclared wheat

    Shakespeare's Pizza is recalling 18,712 frozen pizzas due to undeclared wheat. The product was sold in retail stores in Missouri and Kansas and through online sales; consumers with wheat allergies should not consume it.

    Product
    Shakespeare's Pizza, Extra Cheese Pizza, 25 oz, Keep Frozen; UPC 686 148 007 370; pack size 20 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0577-2024·2023-12-27

    AcuMatch Hip System Recalled for Loss of Vacuum Integrity

    Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.

    Product
    AcuMatch Hip System, Catalog Number 142-32-27
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Drugs)·D-0157-2024·2023-12-27

    Nystatin Bulk Powder Recall for Incorrect Label Assay Value

    Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.

    Product
    NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0607-2024·2023-12-27

    Frozen vegetarian pizza recalled for undeclared wheat allergen

    Shakespeare's Pizza Vegetarian Pizza is being recalled because it contains undeclared wheat, a common allergen. Affected products were distributed to retail stores in Missouri and Kansas and through online direct sales.

    Product
    Shakespeare's Pizza, Vegetarian Pizza, 25 oz, Keep Frozen; UPC 686 148 007 394; pack size 18 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0573-2024·2023-12-27

    Injection Needles Recalled for Inadequate Manual Cleaning Process

    Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.

    Product
    Injection Needle, LUER-lock,0.8mm, REF: 26175PD
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0608-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error

    Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
    Category
    Medical Device
    Distribution
    Distributed nationwide