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.

9076–9100 of 88183

  • 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 (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
  • 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 (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 (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…
    Category
    Food
    Distribution
    3 states
  • 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-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-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 (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…
    Category
    Food
    Distribution
    3 states
  • 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)…
    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…
    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…
    Category
    Food
    Distribution
    3 states
  • 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 (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…
    Category
    Medical Device
    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…
    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 (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…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0463-2025·2025-02-12

    NuGo Dark Pretzel Chocolate Chip Bars Recalled for Undeclared Milk

    Bazzini LLC is recalling NuGo Dark Pretzel/Chocolate Chip Multipack bars due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    NuGo Dark Pretzel/Chocolate Chip Multipack 18 ct., 50g bar, 18 bars/tray, 9 trays/case. 40case/pallet
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0223-2025·2025-02-12

    Adrenalin Chloride Epinephrine Nasal Solution Recalled for Misleading Label

    Par Pharmaceutical is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution) due to a misleading label that resembles the FDA-approved Adrenalin epinephrine injection product, creating potential confusion.

    Product
    Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0464-2025·2025-02-12

    Pita bread recall due to undeclared milk allergen

    Cairo Bakery Pita Pocket Bread is recalled for containing undeclared milk. Packages with code 01/18 distributed in California may be affected.

    Product
    CAIRO BAKERY PITA POCKET BREAD TRADITIONAL RECIPE EXTRA LARGE 6 COUNT, NET WT. 16 OZ. (1 lb.) (454g)
    Category
    Food
    Distribution
    1 state
  • 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
  • SevereFDA (Food)·F-0530-2025·2025-02-12

    White Maeng da Kratom Powder Recalled for Possible Salmonella Contamination

    COREPACK MANUFACTURING INC is recalling White Maeng da kratom powder due to possible Salmonella contamination. The affected product was distributed throughout the United States.

    Product
    White Maeng da, kratom powder product packaged mylar resealable bags. 3 oz package, 80 bags per shipper box.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0534-2025·2025-02-12

    Imported Prepared Monkfish Liver Recalled for Undeclared Milk Allergen

    Mutual Trading Company is recalling ANKIMOBO brand prepared monkfish liver (UPC: 72546611224) because the product contains an undeclared milk allergen. The product poses a risk to consumers with milk allergies.

    Product
    Product is individually packaged in opaque airtight plastic packaging with Chinese lettering on one side. Opposite side contains English label that reads: #61122; ANKIMOBO (prepared Monkfish Liver) Ingredients: Monkfish Liver, Brewed Alcohol, (Rice, Rice Malt), Enzyme.…
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0466-2025·2025-02-12

    Atkinson's Hushpuppies Recalled Due to Undeclared Milk Allergen

    Atkinson Milling Company is recalling Atkinson's Hushpuppies with Onions due to undeclared milk. The product was not labeled as containing milk, posing a risk to consumers with milk allergies.

    Product
    ATKINSON'S HUSHPUPPIES WITH ONIONS NET WT. 1LB. (454 g) UPC 0 72119 20718 2 and NET WT. 2 LB. 8 OZ. UPC 0 72119 20305 4 Ingredients: Enriched Whole Grain Corn Meal***Enriched Wheat Flour, Sugar, Onions, Salt, Eggs, Sodium Bicarbonate Sodium Aluminum Phosphate, Acidic Monocalcium…
    Category
    Food
    Distribution
    8 states