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.

7176–7200 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 (Food)·F-0547-2025·2025-02-19

    Made Good Variety Pack recalled for potential metal contamination nationwide

    Riverside Natural Foods is recalling Made Good Variety Pack products nationwide due to potential metal contamination. Consumers should not consume the products and return them to retailers.

    Product
    1. Made Good Variety Pack 37ct 2.MadeGood Variety Pack 7ct
    Category
    Food
    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 (Food)·F-0558-2025·2025-02-19

    Lemon Jelly Sticks recalled for undeclared Yellow #5 and Potassium Sorbate

    The Candy Basket Inc. recalls Lemon Jelly Sticks WHITE because the label fails to disclose Yellow #5 dye and Potassium Sorbate. Consumers with sensitivities to these additives may be at risk.

    Product
    Lemon Jelly Sticks WHITE, item number CB750-W, 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 declar
    Category
    Food
    Distribution
    3 states
  • 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-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 (Devices)·Z-1100-2025·2025-02-19

    Medical laser device recalled for inadequate safety operating instructions

    Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.

    Product
    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2025·2025-02-19

    Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures

    The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1138-2025·2025-02-19

    Stryker Precision Thin Blade Attachments Recalled for Measurement Failure

    Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1129-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.

    Product
    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID E
    Category
    Medical Device
    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 (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
  • ModerateFDA (Food)·F-0535-2025·2025-02-19

    Nestle Toll House Cookie Dough Recalled Due to Improper Storage Conditions

    Target Corporation recalled Nestle Toll House Valentine's Chocolate Chip cookie dough (UPC 028000344085) due to improper storage temperature. The product was distributed in AK, CA, ID, MT, OR, and WA.

    Product
    Nestle Toll House Valentine's Chocolate Chip cookie dough, Makes 20 cookies. Net wt 14 oz. UPC 0 28000-34408 5. Distributed by Nestle USA, Arlington, VA 22209.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0561-2025·2025-02-19

    Raspberry Jelly Sticks recalled for undeclared food dyes and preservatives

    The Candy Basket Inc is recalling Raspberry Jelly Sticks due to undeclared Red #40 and Potassium Sorbate. Products were distributed in California, Oregon, and Washington.

    Product
    Raspberry Jelly Sticks MILK, item number CB747-M, 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 dec
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0559-2025·2025-02-19

    Marionberry Jelly Sticks Recalled for Undeclared Food Additives

    The Candy Basket Inc recalls Marionberry Jelly Sticks due to undeclared food additives and dyes. The product was sold in bulk in California, Oregon, and Washington.

    Product
    Marionberry Jelly Sticks MILK, item number CB745-M, 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 d
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1123-2025·2025-02-19

    BD Pyxis MedStation Auxiliary ES medication cabinet drawer and door failures

    BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.

    Product
    BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2025·2025-02-19

    BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling

    CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.

    Product
    (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2025·2025-02-19

    BD Pyxis MedStation 4000 Recalled for Drawer and Door Failures

    CareFusion 303, Inc. is recalling the BD Pyxis MedStation 4000 medication cabinet due to potential drawer and door failures that could delay access to stored medications.

    Product
    BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0562-2025·2025-02-19

    Raspberry Jelly Sticks Dark recalled for undeclared Red #40 and Potassium Sorbate

    The Candy Basket Inc is recalling Raspberry Jelly Sticks DARK for undeclared Red #40 and Potassium Sorbate. A total of 516 four-pound bulk boxes were distributed in California, Oregon, and Washington.

    Product
    Raspberry Jelly Sticks DARK, Item Number CB747-D, 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 declar
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0560-2025·2025-02-19

    Marionberry Jelly Sticks Recalled Due to Undeclared Food Additives and Dyes

    The Candy Basket Inc recalls Marionberry Jelly Sticks DARK due to undeclared food dyes and additives including Red #3, Blue #1, Potassium Sorbate, and Propylene Glycol.

    Product
    Marionberry Jelly Sticks DARK, item number CB745-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 d
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0462-2025·2025-02-12

    NuGo Dark Chocolate Chip Bars Recalled for Undeclared Milk

    Bazzini LLC is recalling NuGo Dark Chocolate Chip bars because they contain undeclared milk, which poses a health risk to consumers with milk allergies.

    Product
    NuGo Dark Chocolate Chip, Real Dark Chocolate / Vegan. 12g Protein
    Category
    Food
    Distribution
    13 states