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 (Food)·F-0555-2025·2025-02-19

    Orange Jelly Sticks Recalled for Undeclared Food Additives

    The Candy Basket Inc recalls Orange Jelly Sticks MILK for undeclared Yellow #6 and Sodium Benzoate affecting 516 4-lb. boxes distributed in California, Oregon, and Washington.

    Product
    Orange Jelly Sticks MILK, item number CB741-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 declare
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0543-2025·2025-02-19

    Riverside Natural Foods Recalls Birthday Cake Granola Bars for Possible Metal Contamination

    Riverside Natural Foods is recalling Chocolate Drizzled Birthday Cake Granola Bars in multiple sizes nationwide because they may contain metal pieces. Consumers should discard the product or return it to the retailer.

    Product
    1. Chocolate Drizzled Birthday Cake Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Birthday Cake Granola Bars 17oz (20 bars) 4. Chocolate Drizzled Birthday Cake Granola Bars 8.5oz (10 bars) 5. Chocolate Drizzl
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2025·2025-02-19

    Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities

    CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.

    Product
    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
    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 (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-1167-2025·2025-02-19

    Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer

    Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.

    Product
    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1141-2025·2025-02-19

    Spore Test Monitoring System Printing Error May Cause Result Misdirection

    HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.

    Product
    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
    Category
    Medical Device
    Distribution
    50 states
  • 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-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    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-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    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 (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 (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 (Devices)·Z-1166-2025·2025-02-19

    Novation XLE hip implant components recalled for missing barrier layer

    Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.

    Product
    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • 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
  • 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-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-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
  • 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 (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
  • SevereFDA (Food)·F-0467-2025·2025-02-12

    Atkinson's Plain Hushpuppies Recalled Due to Undeclared Milk Allergen

    Atkinson Milling Company is recalling Atkinson's No Onions Plain Hushpuppies due to undeclared milk on the label. Consumers with milk allergies who consume this product risk allergic reaction.

    Product
    ATKINSON'S NO ONIONS PLAIN NO ONIONS HUSHPUPPIES NET WT. 2 LB. 8 OZ. UPC 0 72119 20304 7 Ingredients: Enriched Whole Grain Corn Meal***Enriched Wheat Flour, Sugar, Onions, Salt, Eggs, Sodium Bicarbonate Sodium Aluminum Phosphate, Acidic Monocalcium Phosphate and Natural Flavors.
    Category
    Food
    Distribution
    8 states