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.

7326–7350 of 88183

  • SevereFDA (Food)·H-0116-2025·2025-07-09

    Passion Fruit Mousse Recalled for Undeclared Allergens

    Sabores Fit Bakery is recalling Passion Fruit Mousse (8 oz cups) because the label fails to declare milk, eggs, soy, wheat, and tree nuts allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Passion Fruit Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·H-0167-2025·2025-07-09

    ZENSHI Handcrafted Sushi Hawaiian Roll Recalled for Salmonella Risk

    Harris Teeter is recalling ZENSHI Handcrafted Sushi Hawaiian Roll products because the cucumbers used in production were recalled due to possible Salmonella contamination.

    Product
    ZENSHI HANDCRAFTED SUSHI Hawaiian Roll - Salmon, Tuna 10pc (Brown Rice) Net Wt. 10.6oz UPC 0 23012 94365 3
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0190-2025·2025-07-09

    Harris Teeter ZENSHI Handcrafted Sushi Spicy Roll Shrimp Recall

    Harris Teeter is recalling ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Roll - Shrimp 10pc (Brown Rice) Net Wt. 7.1oz UPC 0 23012 94317 2
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0187-2025·2025-07-09

    ZENSHI Handcrafted Sushi Spicy Roll Salmon recalled for Salmonella

    Harris Teeter is recalling ZENSHI Handcrafted Sushi Spicy Roll - Salmon 10pc due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Spicy Roll - Salmon 10pc Net Wt. 7.1oz UPC 0 23012 94312 7 & 0 23012 95148 1
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·H-0131-2025·2025-07-09

    Harris Teeter Zenshi Handcrafted Sushi Chef Sampler Recalled for Salmonella

    Harris Teeter is recalling Zenshi Handcrafted Sushi Chef Sampler B#3 (15pc, 12.1oz) due to possible Salmonella contamination from recalled cucumbers used in the product.

    Product
    ZENSHI HANDCRAFTED SUSHI Chef Sampler B#3 (Spicy Salmon, Crunchy, Cream Cheese) 15pc Net Wt. 12.1oz (343g) UPC 0 23012 94339 4
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2036-2025·2025-07-09

    BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips

    Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.

    Product
    BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0179-2025·2025-07-09

    Harris Teeter Zenshi Handcrafted Sushi Premium Chef Sampler recalled

    Harris Teeter is recalling Zenshi Handcrafted Sushi Premium Chef Sampler #2 (20-piece trays) because cucumbers used in the product were recalled due to possible Salmonella contamination.

    Product
    ZENSHI HANDCRAFTED SUSHI Premium Chef Sampler #2 (Crunchy Dragon Rainbow, Chili, Dynamite) 20pc Net Wt. 20.1oz UPC 0 23012 94303 5
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2043-2025·2025-07-09

    Medline IV Catheters Recalled for Needle Retraction Failure

    Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2025·2025-07-09

    Philips C9-5EC Ultrasound Transducer Devices Recalled

    Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips C9-5EC Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2025·2025-07-09

    Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips S5-1 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2025·2025-07-09

    ADVIA Hematology System Control Product Recall for Platelet Value Error

    Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2025·2025-07-09

    Medline IV Catheter Kits Recalled Over Needle Retraction Issue

    Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2025·2025-07-09

    Bard Urologist's Tray Recalled Over Incorrect French Size Labeling

    C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.

    Product
    REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2025·2025-07-09

    VITROS 4600 chemistry systems may report results using expired diluent packs

    VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.

    Product
    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2025·2025-07-09

    Apex Knee System components recalled over loss of sterile packaging integrity

    Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.

    Product
    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2025·2025-07-09

    Cardiology hemodynamics software update may cause unexpected system shutdowns

    Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.

    Product
    Change Healthcare Cardiology Hemodynamics Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0500-2025·2025-07-09

    Compounded ketamine injection recalled over lack of sterility assurance concerns

    Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2025·2025-07-09

    Medline retinal packs recalled because catheter needle may fail to retract

    Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0502-2025·2025-07-09

    Compounded lidocaine with epinephrine vials lack assurance of sterility

    Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.

    Product
    LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0498-2025·2025-07-09

    Compounded preservative-free lidocaine vials lack assurance of sterility

    Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.

    Product
    LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0211-2025·2025-07-09

    Meijer dark chocolate almonds recalled for undeclared cashews in packaging

    Frederik's by Meijer Dark Chocolate Almonds are being recalled because of undeclared cashews. 3,301 cases are affected across six states.

    Product
    Frederik's by Meijer Dark Chocolate Almonds 12 oz. resealable bag, UPC 7 08820 68730 1, 6 retail units per wholesale case. Frederik's by Meijer Dark Chocolate Almond 12 oz. box of 8, 1.5 oz. individual serving pouches, UPC 7 19283 11923 0, 6 retail units per wholesale case.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·H-0203-2025·2025-07-09

    Peak Cocktails blood orange spritz cans may overpressurize and explode

    Peak Cocktails Blood Orange Spritz in 8.4 fl oz cans is being recalled because of overpressurization leading to exploding cans. 16,128 units are affected.

    Product
    Peak Cocktails Blood Orange Spritz 8.4 fl oz aluminum cans sold as an individual flavor and in variety packs of 12, 24, and 48 cans. Batch Codes: B25127, B25128; Packaging Date: 05/07/2025, 05/08/2025
    Category
    Food
    Distribution
    50 states
  • HighFDA (Drugs)·D-0501-2025·2025-07-09

    Compounded ketamine multi-dose vials recalled over sterility assurance concerns

    Ketamine Hydrochloride Injection 500 mg/5 mL multi-dose vials compounded by Medivant Healthcare are being recalled for lack of assurance of sterility. 14,725 vials are affected.

    Product
    KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
    Category
    Drug
    Distribution
    Distributed nationwide