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.

13551–13575 of 27206

  • 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-0583-2024·2023-12-27

    Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure

    Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.

    Product
    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0588-2024·2023-12-27

    Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss

    Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.

    Product
    Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0569-2024·2023-12-27

    Orthopedic implant head recall due to incorrect adapter in packaging

    Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
    Category
    Medical Device
    Distribution
    9 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-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 (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 (Drugs)·D-0156-2024·2023-12-27

    Nystatin Bulk Powder Recalled Due to Incorrect Label Strength

    Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.

    Product
    NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2024·2023-12-27

    Abbott Hematology Analyzers Recalled for Unlabeled Latex Component

    Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.

    Product
    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
    Category
    Medical Device
    Distribution
    37 states
  • 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-0606-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias

    Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0602-2024·2023-12-27

    ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification

    Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.

    Product
    ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0603-2024·2023-12-27

    Ice Cream Bar Recalled for Undeclared Food Dyes

    La Michoacana Rompope ice cream bars are being recalled due to undeclared Yellow #5, Yellow #6, and Red #40. The product was distributed only in Florida.

    Product
    ICE CREAM BAR, MICHOACANA, es...natural, ROMPOPE, Net. Wt. 6 Fl. Oz., Packaged in a plastic bag. Frozen.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0560-2024·2023-12-27

    Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing

    Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.

    Product
    Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2024·2023-12-27

    ZEUS ELISA Parvovirus B19 Test Kits Recalled for Unapproved Modification

    Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.

    Product
    ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0595-2024·2023-12-27

    CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current

    The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.

    Product
    CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2024·2023-12-27

    Vero Biotech GENOSYL DS cassette recalled for manufacturing flow defect

    Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.

    Product
    VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0586-2024·2023-12-27

    Exactech knee replacement inserts recalled for vacuum seal loss

    Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.

    Product
    Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0568-2024·2023-12-27

    ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling

    Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.

    Product
    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite
    Category
    Medical Device
    Distribution
    13 states
  • CriticalFDA (Food)·F-0519-2024·2023-12-20

    Wilcox Super Java ice cream recalled due to Listeria contamination risk

    Wilcox SUPER PREMIUM Super Java ice cream (1.5 QT and Pint) may be contaminated with Listeria. Affected products were distributed in VT, NH, MA, and NY with Best By/Sell By dates from 9/13/24 to 11/14/24.

    Product
    Wilcox SUPER PREMIUM Super Java; 1.5 QT (UPC 04372601516) and Pint (UPC 04372601616)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0579-2024·2023-12-20

    Cantaloupe Recall: Salmonella Risk in Malichita Whole Cantaloupe

    PACIFIC TRELLIS FRUIT, LLC is recalling Malichita brand whole cantaloupes in 9-count and 12-count packages due to potential Salmonella contamination. The recall affects 4,872 cases distributed in Wisconsin, Oklahoma, Illinois, Texas, California, and Canada.

    Product
    Malichita brand Whole Cantaloupe 9 count and 12 count
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0525-2024·2023-12-20

    Wilcox Ice Cream Bar Recalled for Potential Listeria Contamination

    Wilcox Ice Cream Bar (Black Raspberry) is being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Ice Cream Bar (Dairy Based) Black Raspberry (UPC 043726005065)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0516-2024·2023-12-20

    Wilcox Ice Cream Recalls Maple Cream for Potential Listeria Contamination

    Wilcox Ice Cream is recalling Maple Cream in 1.5 quart and pint sizes due to potential Listeria monocytogenes contamination. The affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September 13 to November 14, 2024.

    Product
    Wilcox SUPER PREMIUM Maple Cream; 1.5 QT (UPC 04372601510) and Pint (UPC 04372601610)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0592-2024·2023-12-20

    Acorn Raspberry Creme Cookies Recalled for Undeclared Tree Nut Allergen

    Houdini Inc. is recalling Acorn Raspberry Creme Filled Cookies found in gift baskets due to undeclared tree nuts. The cookies were distributed nationwide to all U.S. states.

    Product
    Acorn Raspberry Creme Filled Cookie found in gift basket: #343 Brownie, Cookie & Cake Assortment
    Category
    Food
    Distribution
    49 states