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.

14426–14450 of 88183

  • SevereFDA (Food)·F-0875-2024·2024-02-21

    Fresh Express Chopped Salad Kit Southwest Recalled for Listeria Risk

    Fresh Express Incorporated is recalling Chopped Salad Kit Southwest products due to potential Listeria monocytogenes contamination in the cheese condiment pack. Consumers should not consume the product.

    Product
    Chopped Salad Kit Southwest with condiments(toppings that include cheese), labeled salad bag (Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onions, Tortilla Strips, Cheddar Cheese, and Chipotle Ranch Dressing), Net Wt 13.4 oz, 6 bags per case. UPC…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0962-2024·2024-02-21

    GE Healthcare Lullaby Incubator bedside panels may fail to latch properly

    GE Healthcare Lullaby Incubator bedside panels and portholes may appear closed but not be properly latched. If impacted, these panels can disengage and fall open, creating a fall risk for patients.

    Product
    GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1067-2024·2024-02-21

    Bone void filler recalled due to manufacturing process control issue

    Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.

    Product
    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1140-2024·2024-02-21

    FilmArray GI diagnostic kits recalled due to false positive Norovirus results

    BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.

    Product
    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images

    The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.

    Product
    CombiDiagnost R90 1.0 (709030)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2024·2024-02-21

    FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect

    Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.

    Product
    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2024·2024-02-21

    Olympus Duodenovideoscope Distal Cover may detach during gastrointestinal procedures

    Olympus Single Use Distal Cover MAJ-2315 may detach from duodenovideoscopes during gastrointestinal procedures, risking perforation, retained objects requiring urgent removal, burns, and airway obstruction.

    Product
    Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2024·2024-02-21

    Medical Device Control Panel Contaminated with Norovirus, Causes False Positive Results

    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) negative control is contaminated with Norovirus. Users testing this control will incorrectly receive positive Norovirus results.

    Product
    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2024·2024-02-21

    Captus 4000e Thyroid Uptake Systems spring failure poses fall risk

    Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.

    Product
    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2024·2024-02-21

    OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility

    OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.

    Product
    Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1074-2024·2024-02-21

    Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk

    Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0870-2024·2024-02-21

    Tzatziki Yogurt Recalled for Undeclared Milk Allergen in Oregon and Washington

    Al Amir Fresh Foods Tzatziki Cucumber Yogurt is recalled due to undeclared milk on the label. The product contains sour cream and yogurt but does not declare milk as an ingredient, posing a risk to milk-allergic consumers.

    Product
    Al Amir Fresh Foods Tzatziki Cucumber Yogurt, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 8 55134 12351 3. The recalled product label declares: Ingredients: Sour Cream, Yogurt, Cucumber, Dry Dill Weed, Garlico…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0872-2024·2024-02-21

    Woodstock 5 Grain Cereal recalled for undisclosed wheat allergen

    Woodstock 5 Grain Cereal is recalled because triticale, a product ingredient, is not identified as wheat on the label. This creates a risk for people with wheat allergies.

    Product
    Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908. Packaged in a plant that also processes wheat.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0325-2024·2024-02-21

    Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure

    IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1089-2024·2024-02-21

    global Medium embryo culture media recalled for potential development impairment

    CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.

    Product
    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2024·2024-02-21

    Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use

    Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.

    Product
    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0871-2024·2024-02-21

    Dannon Plain Yogurt 32oz cartons recalled for potential sanitizer contamination

    DANONE US LLC is recalling Dannon Plain Yogurt 32oz cartons distributed in Georgia due to potential contamination with sanitizer. The affected product expires 03/13/24.

    Product
    Dannon Plain Yogurt packaged in 32oz plastic carton with lid - 6 cartons per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1078-2024·2024-02-21

    Skin Graft Carrier Recalled for Manufacturing Ratio Defect

    Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.

    Product
    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2024·2024-02-21

    Philips Recalls ProxiDiagnost Radiography Systems for Patient Data Display and Security Issues

    Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.

    Product
    ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2024·2024-02-21

    Bone Filler Tubes Recalled Due to Manufacturing Process Defect

    The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.

    Product
    AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2024·2024-02-21

    BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results

    BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2024·2024-02-21

    Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk

    NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.

    Product
    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
    Category
    Medical Device
    Distribution
    Distributed nationwide