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.

7151–7175 of 26961

  • HighFDA (Devices)·Z-1122-2025·2025-02-19

    BD Pyxis MedStation ES Medication Cabinet Drawer and Door Failures Recalled

    The FDA is recalling BD Pyxis MedStation ES medication cabinets due to potential drawer and door failures that could delay medication access. Affected healthcare facilities should check their devices and contact the manufacturer if malfunctions occur.

    Product
    BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2025·2025-02-19

    Exactech AcuMatch XLE Hip Implants Recalled Due to Missing Protective Barrier Layer

    Exactech recalled AcuMatch XLE hip implants due to the absence of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Approximately 42 units were distributed in the U.S. and internationally.

    Product
    AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1140-2025·2025-02-19

    Cardiac Diagnostic Implant Recalled for Premature Device Failure

    Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.

    Product
    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0563-2025·2025-02-19

    Cheese powder ingredient blend recalled for plastic thread contamination

    Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.

    Product
    5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Phosphate, Salt], Rice Starch, Sugar, Salt, Encapsulated Baking Soda (Sodium Bicar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0541-2025·2025-02-19

    Riverside Cookies & Creme Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Cookies & Creme Granola Bars nationwide due to possible metal contamination. Consumers should not consume the affected products.

    Product
    1. Cookies & Creme Granola Bars 30.6oz (36 bars) 2. Cookies & Creme Granola Bars 5.1oz (6 bars) 3. Cookies & Creme Granola Bars 0.85 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0545-2025·2025-02-19

    Holiday Sprinkles Chocolate Drizzled Granola Mini Bars Recall for Metal Contamination

    Riverside Natural Foods has recalled Holiday Sprinkles Chocolate Drizzled Granola Mini Bars nationwide because the product may contain metal pieces. Consumers should not consume these bars.

    Product
    1.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 10.5oz (25 bars) 2.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 0.42oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0544-2025·2025-02-19

    Riverside Chocolate Drizzled Cookie Crumble Granola Bars Recalled for Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Cookie Crumble Granola Bars distributed nationwide due to potential metal contamination. Approximately 2.4 million cases are affected.

    Product
    1. Chocolate Drizzled Cookie Crumble Granola Bars 4.2oz (5 bars) 2. Chocolate Drizzled Cookie Crumble Granola Bars 25.5oz (30 bars) 3. Chocolate Drizzled Cookie Crumble Granola Bars 0.85oz 4. Chocolate Drizzled Granola Bars Variety Pack 25.5oz (30 bars)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2025·2025-02-19

    Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0540-2025·2025-02-19

    Strawberry Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Strawberry Granola Bars nationwide due to potential metal contamination. Consumers should stop consuming the product and dispose of it safely.

    Product
    1. Strawberry Granola Bars 30.6oz (36 bars) 2. Strawberry Granola Bars 5.1oz (6 bars) 3.Strawberry Granola Bars 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource ACDF Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource ACDF surgical kits for potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses or injuries have been reported.

    Product
    Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2025·2025-02-19

    Irbesartan Tablets Recalled Due to Out-of-Specification Dissolution

    AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2025·2025-02-19

    Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk

    Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.

    Product
    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2025·2025-02-19

    Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings

    Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.

    Product
    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.

    Product
    Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2025·2025-02-19

    LVIS Intraluminal Support Device May Fail to Deploy Properly

    MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.

    Product
    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1163-2025·2025-02-19

    HPV Diagnostic Control Panel Recall Due to Quality Control Failures

    Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2025·2025-02-19

    MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect

    Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.

    Product
    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0557-2025·2025-02-19

    Lemon Jelly Sticks DARK Recalled for Undeclared Yellow #5 and Potassium Sorbate

    The Candy Basket Inc is recalling Lemon Jelly Sticks DARK (item CB750-D) for containing undeclared Yellow #5 and Potassium Sorbate. The product was sold in bulk boxes without retail packaging across California, Oregon, and Washington.

    Product
    Lemon Jelly Sticks DARK, item number CB750-D, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declares
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0546-2025·2025-02-19

    Chocolate Drizzled Vanilla Granola Bars Recalled for Potential Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Vanilla Granola Bars nationwide due to potential metal piece contamination. Affected products should not be consumed.

    Product
    1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Vanilla Granola Bars 0.85oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2025·2025-02-19

    Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination

    Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.

    Product
    Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0539-2025·2025-02-19

    Mixed Berry Granola Bars Recalled for Possible Metal Contamination

    Riverside Natural Foods is recalling Mixed Berry Granola Bars nationwide (2.4 million cases) because they may contain metal pieces. Affected consumers should not eat the product and should contact the manufacturer for a refund.

    Product
    1. Mixed Berry Granola Bars; 34oz (40 bars) 2. Mixed Berry Granola Bars; 5.1oz (6 bars) 3.
    Category
    Food
    Distribution
    Distributed nationwide