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.

12601–12625 of 88183

  • HighFDA (Food)·F-1426-2024·2024-07-03

    Chocolate Chunk Cookie Mix Recalled for Undeclared Coconut Allergen

    Penguin Natural Foods is recalling 'THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen' because the product contains undeclared coconut. Consumers with coconut allergies face a serious health risk.

    Product
    "THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen NET WT. 15.76 OZ (447g)" Packaged in a beige cardboard box, with green lettering
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1430-2024·2024-07-03

    Chef Select Herb Baguettes Recalled for Undeclared Wheat and Milk Allergens

    Lidl US TRADING is recalling approximately 2,000 units of Chef Select 2 Herb Baguettes due to undeclared wheat and milk allergens resulting from foreign language labeling. Consumers with wheat or milk allergies should not consume this product.

    Product
    Chef Select 2 Herb Baguettes Filled With Herb Butter 2x175 g Barcode: 4056489447566. Frozen product packaged in a plastic bag, 2 baguettes per unit.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2186-2024·2024-07-03

    Siemens Multix TOP X-ray Table Recalled Due to Fire Risk

    Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2024·2024-07-03

    Fresh Catch Inc. Yellowfin Tuna Recalled for High Histamine Levels

    Fresh Catch Inc. is recalling Yellowfin Tuna for high histamine levels. No illnesses have been reported.

    Product
    Fresh Catch Inc. Yellowfin Tuna, 1 loin per case packaged in carboard boxes with keep refrigerated label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2190-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.

    Product
    COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2024·2024-07-03

    Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects

    Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.

    Product
    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect

    Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2024·2024-07-03

    Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction

    Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.

    Product
    The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1405-2024·2024-07-03

    Wakefield Ham, Egg & Cheese Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 1,366 cases of Wakefield Ham, Egg & Cheese Muffins due to possible Listeria monocytogenes contamination. The affected products were distributed across 14 states.

    Product
    (Item 806604) Wakefield Ham, Egg & Cheese Muffin
    Category
    Food
    Distribution
    14 states
  • HighFDA (Drugs)·D-0564-2024·2024-07-03

    Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue

    Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2024·2024-07-03

    Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect

    Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.

    Product
    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1398-2024·2024-07-03

    Wakefield Southern Chicken Biscuit recalled for possible Listeria contamination

    Classic Delight LLC is recalling Wakefield Southern Chicken Biscuit (Item 176594) due to possible Listeria monocytogenes contamination. The product was distributed in 14 states with multiple affected lot numbers.

    Product
    (Item 176594) Wakefield Southern Chicken Biscuit
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2170-2024·2024-07-03

    Patient Monitors May Fail to Display Vitals After Power Loss

    GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1396-2024·2024-07-03

    Classic Delight Breaded Chicken Waffle Recalled for Possible Listeria Contamination

    Classic Delight Breaded Chicken Waffle (Item 7626) for institutional use is being recalled due to possible contamination with Listeria monocytogenes. The recall affects 644 cases distributed to institutions in 14 states.

    Product
    (Item 7626) Classic Delight Breaded Chicken Waffle - INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2173-2024·2024-07-03

    Sight OLO CBC Test Kit Lot Recalled for Bacterial Contamination

    One lot of Sight OLO CBC Test Kit is being recalled due to bacterial contamination that causes artificially elevated platelet counts. The affected kits may produce inaccurate test results.

    Product
    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2024·2024-07-03

    NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk

    FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.

    Product
    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2220-2024·2024-07-03

    CDC Influenza H5 Subtyping Kit may produce inconclusive test results

    The CDC Influenza A/H5 Subtyping Kit's H5b component may fail to amplify, resulting in inconclusive results. 191 units were distributed nationwide.

    Product
    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0566-2024·2024-07-03

    Extra Strength Acetaminophen 500mg Tablets Recalled for Discoloration

    Contract Pharmacal Corporation is recalling 14,616 bottles of Extra Strength Acetaminophen 500mg tablets due to discoloration appearing as brownish tablets. The affected lot was distributed in Michigan.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2178-2024·2024-07-03

    Sonic Scaler Tip Holder May Be Oversized, Preventing Proper Seating

    The tip holder portion of Titan Blis-Sonic Scaler tips may be oversized, preventing proper seating in the scaler handpiece. This defect could result in the tip becoming loose during use.

    Product
    Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2223-2024·2024-07-03

    Cook Drainage Catheter Recall: Incorrect Expiration Date Labels

    Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.

    Product
    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0569-2024·2024-07-03

    SinuFrin Nasal Decongestant Recalled for Sub-Potency Nationwide

    NeilMed Pharmaceuticals is recalling 20,370 bottles of SinuFrin Quick Relief Decongestant (Lot SD134) nationwide due to sub-potency. No illnesses have been reported.

    Product
    SINUFRIN QUICK RELIEF DECONGESTANT — SINUFRIN QUICK RELIEF DECONGESTANT (SINUFRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1388-2024·2024-06-26

    New Seasons Market Strawberry Rhubarb Bakewell Tart Recalled for Undeclared Almond

    New Seasons Market is recalling its Strawberry Rhubarb Bakewell Tart due to undeclared almond. The 261 units distributed in Oregon and Washington pose an allergen risk to consumers with almond allergies.

    Product
    New Seasons Market Strawberry Rhubarb Bakewell Tart, packaged in a plastic clamshell with scale label. Contains Milk, Wheat, Eggs.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2130-2024·2024-06-26

    Ventilator Operator's Guide Recalled for Missing Critical MRI Safety Information

    ZOLL is recalling operator's guides for the ZOLL 731 Ventilator because they omit critical MRI safety information. Missing distance guidance could cause the ventilator to malfunction during MRI procedures.

    Product
    ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7.…
    Category
    Medical Device
    Distribution
    Distributed nationwide